Devices, assemblies, and methods for controlling fluid flow

ABSTRACT

Connector assemblies are provided for controlling flow in a fluid line that include an outer shell, an inner housing, and a tubular member. The inner housing is disposed within the outer shell and includes a boss disposed adjacent a first end of the outer shell. The inner housing is movable axially within the outer shell between first and second positions when a device is connected to the first end. The tubular member is carried by the inner housing and includes a fluid passage extending between a second end of the outer shell. The tubular member moves axially as the inner housing moves between the first and second positions, and cam features on the outer shell and the tubular member cause the tubular member to rotate as the inner housing moves between the first and second positions, thereby opening a fluid path between the fluid passage and the first end.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/914,381, filed on Jun. 10, 2013, which is a continuation of U.S.patent application Ser. No. 13/163,999 filed on Jun. 20, 2011, nowissued as U.S. Pat. No. 8,460,252 on Jun. 11, 2013, which is acontinuation of U.S. patent application Ser. No. 12/920,807 filed onSep. 2, 2010, now issued as U.S. Pat. No. 8,414,542 on Apr. 9, 2013,which is a 371 application of international application No.PCT/US2009036088 filed on Mar. 4, 2009, which claims the benefit of U.S.Prov. Pat. App. Ser. No. 61/033,702 filed on Mar. 4, 2008, and thecontents of each of the aforementioned applications are incorporatedherein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods forcontrolling flow. More particularly, the present invention relates todevices, assemblies, and/or methods for controlling fluid flow, e.g., toconnectors and/or valves for controlling flow through an IV or otherfluid line into a patient, a syringe, container, and/or other medicaldevice, and/or to systems including such connectors and/or valves.

BACKGROUND

Controlling flow is an important and useful tool in virtually allscientific fields. One such field where controlling flow is highlyuseful is in the medical arena. For example, it may be useful to controlflow during infusion, e.g., when introducing fluid into a blood vessel,such as a vein, via a fluid line for therapeutic and/or diagnosticpurposes. The fluid introduced may be saline solution, plasma solution,glucose solution, antibiotics, pain relievers, nuclear medicine agents,and the like. Infusion may involve many fluid doses into a patient overlong periods of time. Early in the infusion field, each fluid doserequired a new needle to be inserted into the vein. Repeated insertionof a needle into the same vein of a patient, however, may damage thevein, increase the potential for bruising, and/or inflict pain on ordiscomfort to the patient.

Health professionals quickly changed this routine by inserting oneneedle into the patient's vein, and leaving it there for initial andsubsequent fluid dose introductions. This stationary needle could beconnected to a first or proximal end of a catheter that had an openingat a second or distal end for receiving fluid from a syringe or otherdevice. For example, a latex cap was placed over the distal end of thecatheter, which could be penetrated by a beveled hollow needle. Onceinserted into the patient's vein, the stationary needle could be securedwith tape, but was prone to disconnection from the patient. From thisbasic concept, a range of needleless connectors were developed capableof linking the fluid line to the patient's catheter directly therebybypassing needle use. Further industry directive and federal regulationencouraged this alternative technique of promoting needlelessconnectors' use, thereby promoting removal of sharp instruments from thepatient area.

Early needleless connectors featured a split septum on the female end(e.g., the end closer to the patient during connection). The splitseptum could be opened by inserting a cannula. The male end featured ablunt cannula, which was inserted into the split-septum on the femaleend. This method relieved some of the disconnection problems, but a newproblem emerged. Removing the blunt cannula created a negative pressureinside the catheter, which caused a small amount of blood from thepatient to flow into the proximal end of the catheter. These smallamounts of blood would accumulate in the catheter, thereby clogging thefluid pathway. The consequence of this negative pressure, or negativebolus effect, was to require a new, clean catheter. The replacement ofthese clogged catheters may be expensive and/or painful to the patient.

The split septum on the female end was then replaced with an anti-refluxvalve activated by the use of a male-female Luer configuration, alsotermed sequential valving. This male-female Luer connection has beenstandardized by the industry, e.g., through international standard ISO594-2 “Conical fittings with a 6% (Luer) taper for syringes, needles andcertain other medical equipment”, Part 2: Lock fittings.

The demand for closed needleless systems for fluid administration isdriven, at least partially, by the safety concerns associated withmedications that are toxic to healthcare workers that prepare andadminister these medications. These medications include chemotherapy andradiotherapeutic agents. Key industry organizations, such as theNational Institute for Occupational Safety and Health (NIOSH), OncologyNursing Society (ONS), and American Society of Health System Pharmacists(ASHP), recommend adopting closed systems to minimize drips, leaks, orspills of the drug to help eliminate surface contamination and exposure.

The vast majority of the self-sealing medical connectors that are usedfor the administration of parenteral fluids are designed with anunsealed male Luer connector on the end that remains connected to thepatient's IV line, fluid source, etc., and a female connector on theopposite free end of the connector through which a syringe or othertypes of devices is connected. In many devices on the market, there is aself sealing valve built into the female connector. The male Luertypically does not have an internal valve, and as such, any remainingfluid is capable of being exposed to care providers and/or patients upondisconnection of the unsealed male Luer. As mentioned above, for certainapplications, the fact that residual volume of the fluid may be unsealedand/or exposed to individuals around the IV system may pose significanthealth hazards. Additionally, these conventional Luer connectors mayhave a larger internal volume in which fluid may collect, and alsoemploy many parts thereby increasing the potential for error inmanufacturing or during use.

The standard connection mechanism for these Luer connectors involvesaligning the threads together by a helical threading action. Thisthreading action is meant to establish a connection between (e.g.,engage) the two Luer ends, and is not the force used to open or close(e.g., actuate) fluid pathways. As the two Luer connectors are beingconnected together, there is a separate translational (e.g., on avertical axis) action within these connection assemblies that acts toengage the fluid pathways. Traditionally, the female end has a thread onthe outside while the male has a thread on the inside. Since most femaleends have self-sealing valves, the user may open the fluid path with thetranslational force during engagement or after the male end iscompletely engaged and locked inside the female end. Thus, the user maynot know at what point the fluid path is sufficiently opened or closedduring connection and disconnection of the two connectors. The user onlyknows that the fluid path is closed (e.g., the two connectors aredeactuated), when the two connectors are completely disengaged, ordisconnected, and separated.

Thus, there is a need in the art for a connector and/or connectingassembly that may effectively avoid uncertainty in the actuationprocess, avoid certain undesired pressure effects, create certaindesired pressure effects, reduce the internal volume of the assemblies,and/or decrease the number of members required for manufacturing.

SUMMARY OF THE INVENTION

The present invention is directed to apparatus and methods forcontrolling flow through a fluid line or device, for example, toconnectors and/or valves for delivering fluid via an intravenous (“IV”)or other medical fluid line into a patient, a syringe, container, and/orother medical device, and to systems including such connectors and/orvalves.

Conventional devices and assemblies for establishing medical connectionsare not completely effective and are potentially unsafe. For example,conventional medical connectors may expose the user to harmful agentsduring disconnection as a result of undesired bolus effects, may collectundesired fluid within their internal volumes after disconnection, maynot notify the user of the actuation status during connection anddisconnection, and/or may include many parts thereby making manufactureexpensive. In contrast, embodiments herein may use fewer parts, mayminimize and/or eliminate residual fluid within the connectors afterdisconnection, may utilize a rotational actuation force as opposed totranslation force to avoid or create a desired bolus effect, and/or mayincorporate actuation status indicators to notify the user whenactuation is complete.

In exemplary embodiments, medical connectors disclosed herein may beused for the administration of parenteral fluids, such as needlelessconnectors that may offer alternative mechanisms to conventional Luerconnectors, may utilize a visual indicator that provides instantfeedback to an operator regarding actuation status, and/or may employalternative ways for energy storage, including rotational force,electromagnetic, polymer torsion spring, and/or spring washers foractuation.

As used herein, “proximal” refers to a first end of the device, e.g.,the portion of the device or component that is closer to the patientwhen the device or component is properly positioned, for example, on apatient's IV line. “Distal” refers to a second opposite end of thedevice, e.g., the portion of the device or component that is fartherfrom the patient when the device or component is properly positioned,for example, on a patient's IV line. For reference, the female end maybe upstream in an IV flow circuit and the male may be downstream or viceversa. “Actuated” refers to the condition in which the fluid path isopened to allow fluid to transfer freely along the fluid path, while“deactuated” refers to the condition in which the fluid path is closedand fluid transfer is not permitted. “Engaged” refers to the conditionin which two members that are designed for connection, for example, Luerconnectors, are physically connected to each other in a manner in whichthey are designed to be connected, while “disengaged” refers to thecondition in which two members, for example, Luer connectors, arephysically disconnected from one another. When two members are referredto as “engaged,” they may or may not be “actuated.” The two members are“actuated” only when they are fully engaged, and fluid transfer ispermitted between them. Alternatively, one member may use one valvecomponent (male or female) and a passive (non-valved) element ofopposite gender. “Female” Luer connector refers to a connecting memberthat includes a Luer thread on its outer surface. “Male” Luer connectorrefers to a connecting member that includes a Luer thread on its innersurface. “Passive” refers to the conditions under which a connector orassembly functions, and signifies that the assembly is capable ofdeactuating automatically as it is disengaged. “Non-Passive” refers tothe conditions under which a connector or assembly functions, andsignifies that the assembly does not automatically deactuate as it isdisengaged, but requires a separate action. Optionally, in theembodiments herein, there may be sequential valving, resulting inco-dependent or independent actuation of male and/or female sides ofvalves.

In accordance with an exemplary embodiment, a connector assembly isprovided for controlling flow in a fluid line. The connector assemblymay include an outer shell, an inner housing, and a tubular member. Theouter shell may include a first end, a second end, and a passageextending therebetween. The inner housing is disposed within the outershell and may include a boss disposed adjacent the first end. The innerhousing may be movable axially within the outer shell between a firstposition adjacent the first end and a second position further from thefirst end than the first position when a device is connected to thefirst end of the outer shell.

The tubular member may be disposed within the inner housing and mayinclude a fluid passage therein extending between the second end of theouter shell and the boss of the inner housing. The tubular member may becarried by the inner housing such that the tubular member moves axiallyas the inner housing moves between the first and second positions. Theconnector assembly may also include cam features on the outer shelland/or the tubular member for causing the tubular member to rotate asthe inner housing moves between the first and second positions, therebyopening a fluid path between the fluid passage in the tubular member andthe first end of the outer shell.

For example, when a device is connected to the first end of the outershell, the tubular member may rotate relative to the inner housing toallow fluid flow through the assembly with the device connected to thefirst end of the outer shell. Optionally, the inner housing may bebiased to the first position, e.g., to bias the tubular member to closethe fluid path.

In accordance with another embodiment, a connector and/or valve assemblyis provided for controlling flow in a fluid line that includes an outershell including a first end, a second end, and a passage extendingtherebetween, the first end including a connector for connecting theassembly to a fluid line; an inner housing disposed within the outershell and including a boss disposed adjacent the first end, the innerhousing being movable axially within the outer shell between a firstposition adjacent the first end and a second position further from thefirst end than the first position when a device is connected to theconnector on the first end of the outer shell; a tubular member disposedwithin the inner housing and including a fluid passage therein extendingbetween the second end of the outer shell and the boss of the innerhousing, the tubular member carried by the inner housing such that thetubular member moves axially as the inner housing moves between thefirst and second positions; and cam features on the inner housing andthe tubular member for causing the tubular member to rotate as the innerhousing moves between the first and second positions, thereby opening afluid path between the fluid passage in the tubular member and the firstend of the outer shell to allow fluid flow through the assembly with thedevice connected to the first end of the outer shell.

In accordance with another embodiment, a connector assembly forcontrolling flow in a fluid line is provided that includes an outershell or bezel including a first end, a second end, and a passageextending therebetween, the first end including a connector forconnecting the assembly to a fluid line. An inner housing may bedisposed within the outer shell that includes a boss disposed adjacentthe first end, the inner housing being movable axially within the outershell between a first position adjacent the first end and a secondposition further from the first end than the first position when adevice is connected to the connector on the first end of the outershell. A backing member may be coupled to the second end of the outershell such that the outer shell is substantially axially fixed relativeto the backing member and rotatable relative to the backing member, thebacking member slidably coupled to the inner housing such that the innerhousing moves helically relative to the backing member when the innerhousing is directed from the first position towards the second position.A tubular member may include a first end disposed within the innerhousing and a second end extending through the backing member, thetubular member slidably coupled to the backing member such that thetubular member substantially rotationally fixed relative to the backingmember and is movable axially relative to the backing member, thetubular member comprising a fluid passage therein extending between thefirst and second ends. A seal on the boss may engage the first end ofthe tubular member in the first position to substantially seal the fluidpassage, and cam features may be provided on the inner housing and thetubular member for coupling axial movement of the tubular member toaxial movement of the inner housing when the inner housing is initiallymoved from the first position towards the second position, the camfeatures causing the tubular member to move distally relative to theinner housing immediately before the inner housing reaches the secondposition, thereby disengaging the seal from the first end of the tubularmember and opening the fluid passage.

In accordance with still another embodiment, a dual valve assembly isprovided that includes first and second valves coupled to a commonbacking member and/or sharing a common fluid path. The fluid path mayremain substantially closed until both valves are opened, e.g., when acomplementary Luer fitting or other connector is coupled to respectiveends of the first and second valves. Each valve may include an outerhousing or bezel, an inner housing or covering body, a tubular member, acamming member, and a spring or other elastic member. For example, theelastic member may bias the tubular member to a closed position withinthe respective bezel, while the camming member may cooperate to open therespective valve, e.g., during connection of a Luer fitting to thebezel. The valves may be configured to provide a positive, negative, orsubstantially zero pressure differential within the assembly and/orwithin the adjacent fluid line during actuation and/or deactuation ofthe valves of the assembly.

Methods for using such connector and/or valve assemblies are alsoprovided.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate exemplary embodiments of the invention, inwhich:

FIG. 1A is a perspective view of an exemplary embodiment of a passiveconnecting valve assembly including an outer shell or bezel with a Luerthread and status windows, and a section of tubing extending from adistal end of the outer shell.

FIG. 1B is an exploded view of the passive connecting assembly of FIG.1A, showing the outer shell with a proximal throughbore including a Luerthread, a distal fluid path and status windows; a covering bodyincluding a male boss with a deformable membrane and an outer matingsurface including status indicators; a shaft with an elastic member anda mating member; a backing member with cam elements for interacting withthe mating member, and the section of tubing.

FIG. 2 is a perspective view of an exemplary embodiment of the outershell of the connecting assembly of FIGS. 1A and 1B that includesproximal and distal throughbores, a proximal Luer thread, and statuswindows.

FIG. 3 is a perspective view of an exemplary embodiment of the coveringbody of the connecting assembly of FIG. 1B that includes a male bosswith a deformable membrane, an outer mating surface possessing statusindicators, recesses on a distal side of the outer mating surface forreceiving an elastic member, and a throughbore.

FIG. 4A is a perspective view of an exemplary embodiment of the shaft ofthe connecting assembly of FIG. 1B that includes a conduit, a fluid postwith openings, and a mating member with pegs on its proximal side andcam features on its distal side.

FIG. 4B is a cross-section of the shaft of FIG. 4A taken along line4B-4B.

FIG. 5 is a perspective view of an exemplary embodiment of the backingmember of the connecting assembly of FIG. 1B that includes cam elements,a throughbore, and proximal and distal end segments.

FIGS. 6A(1) and 6A(2) are perspective views of the connecting assemblyof FIGS. 1A and 1B in a deactuated condition, with the outer shellincluded and removed, respectively, showing a Luer connector mating withthe outer shell; the covering body with status indicators that indicatethe deactuated condition; the cam features of the shaft; and the backingmember with its cam elements spaced apart from the cam features.

FIG. 6B is a cross-sectional view of the deactuated connecting assemblyshown in FIGS. 6A(1) and 6A(2), taken along line 6B-6B.

FIG. 6C is a cross-sectional view of the deactuated assembly shown inFIGS. 6A(1) and 6A(2), taken along line 6C-6C.

FIGS. 6D(1) and 6D(2) are perspective views of the connecting assemblyof FIGS. 1A and 1B in an actuated condition, with the outer shellincluded and removed, respectively, showing the Luer connector; thecovering body status indicators that indicate the actuated condition;the cam elements on the shaft engaging with the cam elements on thebacking member.

FIG. 6E is a cross-sectional view of the actuated connecting assemblyshown in FIGS. 6D(1) and 6D(2), taken along line 6E-6E.

FIG. 6F is a cross-sectional view of the actuated assembly shown inFIGS. 6D(1) and 6D(2), taken along line 6F-6F.

FIG. 6G is a perspective view of the deactuated connecting assemblyshown in FIGS. 6A(1) and 6A(2) with the outer shell shown in phantom forclarity.

FIG. 6H is a perspective view of the actuated connecting assembly shownin FIGS. 6D(1) and 6D(2) with the outer shell shown in phantom forclarity.

FIG. 7A is a perspective view of another embodiment of a passiveconnecting assembly including an outer shell with a male Luer threadconnected to an distal end of a length of tubing.

FIGS. 7B and 7C are exploded views of the assembly of FIG. 7A, includingan outer shell with a proximal throughbore containing a Luer thread anda distal throughbore; a covering body including a male boss with adeformable membrane and an outer mating surface; a shaft with an elasticmember and a mating member; and a backing member.

FIG. 8 is a perspective view of the outer shell of the assembly of FIGS.7A-7C.

FIGS. 9A and 9B are perspective views of the shaft of the assembly ofFIGS. 7A-7C.

FIGS. 10A and 10B are perspective views of components of a backingmember of the assembly of FIGS. 7A-7C.

FIG. 11A is a side view of the assembly of FIGS. 7A-7C in a deactuatedcondition before a Luer fitting has been connected to the assembly.

FIGS. 11B and 11C are cross-sectional views of the assembly of FIG. 11A,taken along lines 11B-11B and 11C-11C, respectively.

FIG. 11D is a side view of the assembly of FIG. 11A with the outer shellshown in phantom.

FIG. 12A is a side view of the assembly of FIGS. 7A-7C in an actuatedcondition after the Luer fitting has been connected to the assembly.

FIGS. 12B and 12C are cross-sectional views of the assembly of FIG. 12A,taken along lines 12B-12B and 12C-12C, respectively.

FIG. 12D is a side view of the assembly of FIG. 12A with the outer shellshown in phantom.

FIGS. 13A-13C are perspective views of yet another embodiment of avalve/connector assembly including a female Luer fitting, shown beforeand after connection to a male Luer fitting.

FIGS. 14A and 14B are exploded perspective views of the assembly ofFIGS. 13A-13C.

FIGS. 15A and 15B are cross-sectional views of the assembly of FIGS.13A-13C before and after actuation, respectively.

FIGS. 16A and 16B are cross-sectional views of the assembly of FIGS. 15Aand 15B, taken along lines 16A-16A and 16B-16B, respectively.

FIG. 17A is a perspective view of still another embodiment of a passiveconnecting assembly including an outer shell with a male Luer threadconnected to an distal end of a length of tubing.

FIGS. 17B and 17C are exploded views of the assembly of FIG. 17A,including an outer shell with a proximal throughbore containing a Luerthread and a distal throughbore; a covering body including a male bosswith openings and an outer mating surface; a shaft with an elasticmember and a mating member; a camming element; and a backing member.

FIG. 18 is a perspective view of the outer shell of the assembly ofFIGS. 17A-17C.

FIG. 19 is a perspective view of the covering body of the assembly ofFIGS. 17A-17C.

FIG. 20 is a perspective view of the shaft of the assembly of FIGS.17A-17C.

FIG. 21A is a perspective view of a backing member of the assembly ofFIGS. 17A-17C.

FIG. 21B is a perspective view of a camming element of the assembly ofFIGS. 17A-17C.

FIG. 22A is a side view of the assembly of FIGS. 17A-17C in a deactuatedcondition before a Luer fitting has been connected to the assembly.

FIGS. 22B and 22C are cross-sectional views of the assembly of FIG. 22A,taken along lines 22B-22B and 22C-22C, respectively.

FIG. 22D is a side view of the assembly of FIG. 22A with the outer shellremoved to show the position of the internal components of the assemblybefore actuation.

FIG. 23A is a side view of the assembly of FIGS. 17A-17C in an actuatedcondition after the Luer fitting has been connected to the assembly.

FIGS. 23B and 23C are cross-sectional views of the assembly of FIG. 23A,taken along lines 23B-23B and 23C-23C, respectively.

FIG. 23D is a side view of the assembly of FIG. 23A with the outer shellremoved to show the position of the internal components of the assemblyafter actuation.

FIG. 24A is a perspective view of yet another embodiment of a connectingassembly including an outer shell with a male Luer thread connected to adistal end of a length of tubing.

FIGS. 24B and 24C are exploded views of the assembly of FIG. 24A,including an outer shell with a proximal throughbore containing a Luerthread and a distal throughbore; a covering body including a male bosswith openings and an outer mating surface; a shaft with an elasticmember and a mating member; and a backing member.

FIG. 25 is a perspective view of the outer shell of the assembly ofFIGS. 24A-C.

FIGS. 26A and 26B are perspective views of the covering body of theassembly of FIGS. 24A-24C.

FIGS. 27A and 27B are perspective views of the shaft of the assembly ofFIGS. 24A-24C.

FIGS. 28A and 28B are perspective views of the backing member of theassembly of FIGS. 24A-24C.

FIG. 28C is a perspective view of the backing member of FIGS. 28A and28B, also showing the elastic member of the assembly of FIGS. 24A-24C.

FIG. 29A is a side view of the assembly of FIGS. 24A-24C in a deactuatedcondition before a Luer fitting has been connected to the assembly.

FIGS. 29B and 29C are cross-sectional views of the assembly of FIG. 29A,taken along lines 29B-29B.

FIG. 30A is a side view of the assembly of FIGS. 24A-24C in an actuatedcondition after the Luer fitting has been connected to the assembly.

FIGS. 30B and 30C are cross-sectional views of the assembly of FIG. 30A,taken along lines 30B-30B.

FIGS. 31A and 31B are side and perspective views, respectively, of theassembly of FIG. 29A with the outer shell removed to show the positionof the internal components of the assembly before actuation.

FIGS. 32A and 32B are side and perspective views, respectively, of theassembly of FIG. 30A with the outer shell removed to show the positionof the internal components of the assembly after actuation.

FIGS. 33A and 34A are perspective views of an exemplary embodiment of atube holder including an integral valve in a deactuated condition and inan actuated condition after being connected to a female Luer fitting,respectively.

FIGS. 33B and 34B are cross-sectional views of the tube holder of FIGS.33A and 34A taken along lines 33B-33B and 34B-34B, respectively.

FIGS. 35A and 36A are perspective views of another embodiment of a tubeholder in a deactuated condition and in an actuated condition afterbeing connected to a male Luer fitting, respectively.

FIGS. 35B and 36B are cross-sectional views of the tube holder of FIGS.35A and 36A taken along lines 35B-35B and 36B-36B, respectively.

FIGS. 37A and 37B are perspective and side views, respectively, of anexemplary embodiment of a syringe including an integral valve in adeactuated condition.

FIGS. 38A and 38B are perspective and side views, respectively, of thesyringe of FIGS. 37A and 37B with the valve in an actuated conditionafter being connected to a female Luer fitting.

FIGS. 39A and 39B are perspective and side views, respectively, ofanother exemplary embodiment of a syringe including an integral valve ina deactuated condition.

FIGS. 40A and 40B are perspective and side views, respectively, of thesyringe of FIGS. 39A and 39B with the valve in an actuated conditionafter being connected to a male Luer fitting.

FIGS. 41A, 41B, and 41C are perspective, side, and perspective views,respectively, of an exemplary embodiment of a stand-alone valve assemblyfor connection to a fluid line.

FIGS. 42A, 42B, and 42C are perspective, side, and perspective views,respectively, of another embodiment of a valve assembly for connectionto a fluid line.

FIGS. 43A, 43B, and 43C are perspective, side, and perspective views,respectively, of an exemplary embodiment of a dual valve assembly forconnection to a fluid line.

FIGS. 44A, 44B, and 44C are perspective, side, and perspective views,respectively, of another embodiment of a dual valve assembly forconnection to a fluid line.

FIG. 45A is a perspective view of another embodiment of a connectingassembly including an outer shell with a male Luer thread connected to adistal end of a length of tubing.

FIG. 45B is a perspective view of the assembly of FIG. 45A with portionsof the outer shell and backing member removed to show internalcomponents of the assembly.

FIG. 45C is an exploded view of the assembly of FIG. 45A, including anouter shell with a proximal throughbore containing a Luer thread and adistal throughbore; a covering body including a male boss with openingsand an outer mating surface; and an elastic member between a cammingelement and a backing member.

FIG. 46A is a side view of the assembly of FIGS. 45A-45C in a deactuatedcondition before a Luer fitting has been connected to the assembly.

FIG. 46B is a cross-sectional view of the assembly of FIG. 46A, takenalong lines 46B-46B.

FIG. 46C is a perspective view of the assembly of FIG. 46A before theLuer fitting has been connected to the assembly.

FIG. 47A is a side view of the assembly of FIGS. 45A-45C in an actuatedcondition after the Luer fitting has been connected to the assembly.

FIG. 47B is a cross-sectional view of the assembly of FIG. 47A, takenalong lines 47B-47B.

FIG. 47C is a perspective view of the assembly of FIG. 47A after theLuer fitting has been connected to the assembly.

FIGS. 48A-48D are perspective views of the assembly of FIGS. 45A-47C,showing a sequence of actuation while a Luer fitting is being connectedto the assembly.

FIGS. 49A-49D are perspective views of the assembly of FIGS. 48A-48D,respectively, with portion of the outer shell and backing member removedto show movement of the internal components of the assembly duringactuation.

FIGS. 50A and 50B are perspective details of the assembly of FIGS.45A-49D, showing an outlet port of the assembly closed and open,respectively.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Apparatus and methods described herein may relate to connecting devicesand assemblies that, among other things: utilize a rotational force foractuation to avoid or create a desired bolus effect, minimize the numberof parts necessary for manufacture, decrease the internal volume of thedevices and assemblies, and/or use status indicators to signify whenactuation and deactuation are complete. Also, in some embodiments, theapparatus described herein may create and maintain a flat (planar)surface that is easily swabbed for cleaning and sterilization purposes.Although embodiments of connecting devices and assemblies are describedherein with respect to medical connections, such connecting devices andassemblies are not limited to medical connections alone but may beapplicable to any connection device or assembly that could benefit fromthe use of a rotational actuation force, status indicators, and/or anyof the other features described herein.

For the following description, it should be noted that correspondinglylabeled structures across the figures (e.g., 132 and 232, etc.) maypossess the same general characteristics and/or may be subject to thesame basic structure and function.

An exemplary embodiment of a passive connection assembly 100 is shown inFIGS. 1A and 1B that generally includes a shaft, core pin, conduit, orother tubular member 130, a backing member or cover 140, a covering bodyor inner housing 120, and an outer shell or bezel 110. As explainedfurther below, the shaft 130 may interact with the covering body 120 andbacking member 140 to provide a selectively opened fluid path throughthe assembly 100. The assembly 100 includes interacting cam elementsand/or features, which may translate axial action, e.g., when theassembly 100 is connected to a fluid line, into rotational movement, orrotational action into axial movement to open and/or close the fluidpath. The assembly 100 may be biased to close or open the fluid path,and the bias may be overcome by the axial or rotational action to openor close the fluid path. The outer shell 110 may include one or morewindows 112 that may indicate when the assembly 100 is in open and/orclosed conditions, and/or the assembly 100 may include other indicatorsthat may indicate when the assembly 100 is in the open and/or closedconditions. The assembly 100 may include one or more Luer or otherconnectors, e.g., a male Luer thread 114 as shown on the outer shell110, for connecting the assembly 100 to a fluid line (not shown). Itwill be appreciated that other connectors may also be provided insteadof the Luer thread 114.

FIG. 1B is an exploded view of the assembly 100 showing the outer shell110, along with the covering body 120 with a deformable sleeve ormembrane 129, the shaft 130 with an elastic member 150, and the backingmember 140. The various components of the assembly 100 shown in FIG. 1Bare shown in further detail in FIGS. 2-5 and described further below.

FIG. 2 shows the outer shell 110, which includes one or more statuswindows 112 in an outer surface 111 thereof, an unthreaded portion 115with a distal throughbore 118, and a proximal throughbore 116, e.g., forreceiving the covering body 120 and shaft 130 therethrough. The proximalthroughbore 116 may include the male Luer thread 114 therein. As shown,the outer shell 110 includes a pentagon shaped outer surface 111,although alternatively the outer surface 111 may include other shapes,e.g., to facilitate a user easily gripping and/or manipulating the outershell 110, for example, to engage the male Luer thread 114 with a femaleLuer connector (not shown) via a threading action. Exemplary shapesinclude a triangle, square, hexagon, heptagon, and other suitablepolygons.

The distal throughbore 118 extends through the unthreaded portion 115from distal end 113 of the outer shell 110 to an intermediate location119, which may be situated as shown at or near the midpoint of thelength of outer shell 110, e.g., such that the distal throughbore 118communicates with proximal throughbore 116. The longitudinal distance ofdistal throughbore 118 from the distal end 113 to the intermediatelocation 119 is sufficient to accommodate the outer mating surface 128of covering body 120 (See FIG. 3) and shaft 130 (See FIG. 4A).

The distal throughbore 118 may be pentagonal in shape as shown, or itmay be any other shape (e.g., a triangular, square, pentagonal,hexagonal, heptagonal, octagonal, or other polygonal shape) as long asit is able to receive, effectively contact, and limit movement of thecovering body 120 (See FIG. 3) and the backing member 140 (See FIG. 5)relative to the outer shell 110 when the assembly 100 is being engaging,e.g., with a female Luer connector 160 of a fluid line (not shown, seeFIGS. 6A(1) and 6A(2)). For example, this polygonal shape may ensurethat the outer shell 110, covering body 120, and backing member 140 allrotate substantially in unison. The polygonal shape may also ensure thatthe backing member 140 does not move axially relative to the outer shell110 and/or may allow limited axial motion of the covering body 120within the outer shell 110. The same shape may be used for the distalthroughbore 118 and the outer surface 111 of the outer shell 110, e.g.,for manufacturing convenience, but the device may still function even ifthese shapes are different. The shape and size of the distal throughbore118, however, should correspond substantially to the shape and size ofboth the outer mating surface 128 of the covering body 120 and proximalend segment 144 of the backing member 140, as explained furtherelsewhere herein. Thus, the outer shell 110, covering body 120, andbacking member 140 rotate together, while the shaft 130 (See FIG. 4A)may rotate independently of the other components, also as describedfurther elsewhere herein.

The proximal throughbore 116 may be circular in shape and include theLuer threads 114, as shown in FIG. 2. This facilitates mating the outershell 110 with a female Luer connector 160 (not shown, see FIGS. 6A(1)and 6A(2)), e.g., when engaging the two connectors to couple theassembly 100 with an IV or other fluid line (also not shown). Thelongitudinal distance or depth of the proximal throughbore 116 issufficient to accommodate the male boss 127 of the covering body 120(See FIG. 3) being received therethrough with the proximal end of themale boss 127 projecting past the proximal end 115 of the outer shell110 when the male boss 127 is fitted within the proximal throughbore116. The Luer thread 114 may have conventional dimensions, such as thoseof the ISO industry standards, e.g., to allow compatibility withstandard Luer connectors. The diameter of the distal throughbore 118 maybe large enough to accommodate receiving the covering body 120therethrough, to make contact with and mate with the outer matingsurface 128 (See FIG. 3) of the covering body 120, and/or to fit overand mate with the proximal end segment 144 of the backing member 140.

The status windows 112 may be arranged circumferentially around outersurface 111 of the outer shell 110, as shown in FIG. 2. The windows 112may be rectangular in shape as shown, or may have any other shapeincluding but not limited to circles, triangles, etc., as long as thewindows 112 may fit over and reveal deactuated status indicators 125and/or actuated status indicators 126 on the surface of the coveringbody 120 (See FIG. 3). Although five windows are shown in FIG. 2, anynumber of windows may be provided, e.g., that allow a user to easily seeat least one status indicator 125, 126 during actuation and/ordeactuation. The status windows 112 may be located on the outer surface111 at or near a mid-point along a length of the outer shell 110, orthey may be located elsewhere on the outer surface 111 of the outershell 110 as long as they are capable of revealing one or more of thestatus indicators 125, 126 when in the actuated and/or deactuatedstates. It will be appreciated that the assembly 100 may include otherstatus indicators (not shown) in addition or instead of the statuswindows 112 and status indicators 125, 126, as described elsewhereherein.

FIG. 3 shows the covering body 120, which includes a male boss 127 witha deformable housing 129, a throughbore 123, and status indicators 125,126 disposed on an outer mating surface 128. Also shown in FIG. 3, thecovering body 120 includes recesses 121 for receiving end hubs 151 ofthe elastic member 150, as described further below. Alternatively, thecovering body 120 may include projections (not shown) around which anelastic band or member (not shown) may be secured. In an exemplaryembodiment, the male boss 127 may be dimensioned per ISO industrystandards, and may be cylindrical in shape with a tapered proximal end127 a. During assembly, the outer mating surface 128 may contact thedistal throughbore 118 of the outer shell 110 at or near location 119(not shown, see, e.g., FIG. 2) when the covering body 120 is insertedinto the outer shell 110 (See FIGS. 1A and 1B). The outer mating surface128 may have the same shape and size as the distal throughbore 118 ofouter shell 110 in order for the outer mating surface 128 to fit withinand make contact with the distal throughbore 118 of the outer shell 110,i.e., to allow axial movement but prevent rotation of the covering body120 within the outer shell 110.

The status indicator(s) 125, 126 may be seen in FIG. 3 on the outermating surface 128. The status indicator(s) 125, 126 may signify to auser when actuation and/or deactuation is complete, as describedelsewhere herein. The color or design of the deactuated statusindicator(s) 125 may represent deactuation or a “closed” no-flowcondition for the assembly 100 while the color or design of the actuatedstatus indicator(s) 126 may represent actuation or an “open” or flowcondition for the assembly 100. For simplicity, the deactuated statusindicator 125 is shown with the letter “C” (for “closed”) while theactuated status indicator 126 is shown with the letter “O” (for “open”),although color indicators may be more easily identified during use(e.g., red for closed and green for open). These indicators 125, 126 maybe painted, glued, etched, and/or attached to the outer mating surface128 via any method known in the art. The status indicators 125, 126 mayhave very minimal thickness so as not to increase the girth of the outermating surface 128, i.e., to avoid any increased resistance between theouter mating surface 128 and the outer shell 110.

As the fluid path is actuated during use, the status windows 112 on theouter shell 110 may reveal one or more actuated status indicators 126(see, e.g., FIG. 6D(1)). This signifies that actuation is complete andthat the user should not detach the two mated Luer connectors 114, 160(unless it is desired to close the fluid path). When the user wishes toclose the fluid path, the user may unthread the two Luer connectors andwhen the status windows 112 reveal one or more deactuated statusindicators 125, then deactuation is complete (see, e.g., FIG. 6A(1)).The actuation and deactuation processes are described further below withrespect to the other structural components. It will be appreciated that,optionally, only one set of status indicators may be provided, ifdesired (not shown), e.g., to indicate only the actuated or deactuatedstate, rather than the two sets shown.

The recesses 121 may be located at each corner of the distal side of theouter mating surface 128 (e.g., forming apices of the star-shape), asshown in FIG. 3. The recesses 121, along with their counterpart pegs 131described further below, hold elastic member 150 in place. The recesses121 may have a height such that they are capable of stably holding thehubs 151 of the elastic member 150 in place. As shown, the elasticmember 150 includes a central annular base 152 from which spokes 153extend to the hubs 151. The hubs 151 may be securely received in therecesses 121, e.g., by using an interference fit, bonding with adhesive,sonic welding, and the like. The spokes 153 may be used to store energy,i.e., to bias the elastic member 150, and consequently the shaft 130towards a position corresponding to the closed (or optionally open)condition. For example, as explained elsewhere herein (and shown inFIGS. 6G and 6H), during use, e.g., when connecting and/or opening thefluid path of the assembly 100, the pegs 131 may deform the spokes 153radially when the shaft 130 is rotated, thereby storing energy, whichmay be released when the assembly 100 is closed and/or disconnected.

The elastic member 150 may be composed of any commonly used material inthe art such that it is capable of maintaining a stable, and slightlystretched state (e.g., while in the undeformed star-shape shown in FIG.3), and thereafter being deformed to the configuration illustrated inFIG. 6F. Thus, the elastic member 150 should be strong enough to avoidtearing or breakage when in the deformed state shown in FIG. 6F, beelastic enough to pull itself back into the undeformed star-shape shownin FIG. 3 when allowed, yet not be too resistant to prevent a user frommanipulating it successfully between the two states (e.g., expanded andstar-shapes). It will be appreciated that other energy storage devicesor biasing mechanisms may be provided instead of the elastic member 150,e.g., an elastic band, spring, and the like, as described elsewhereherein.

The throughbore 123 runs the entire length of the covering body 120,e.g., from the outer mating surface 128 through the male boss 127 to thedeformable membrane 129, as shown in FIG. 3. The throughbore 123 may becircular and/or have a diameter exactly or substantially equal to theouter diameter of the conduit 132 of the shaft 130 (not shown, see,e.g., FIG. 4A). The deformable membrane 129 may be located inside theproximal end of the throughbore 123, as shown in FIG. 3, or may bedisposed over the proximal end of the throughbore 123 (not shown). Thedeformable membrane 129 may have a polygonal shaped hollow center 129 athat matches the size and shape of fluid cap 136 of the shaft 130.

The deformable membrane 129 is fixedly attached to the male boss 127,e.g., about its outer circumference, such that the opening 129 a in thedeformable membrane 129 remains substantially stationary while the fluidcap 136 of the shaft 130 rotates, i.e., is capable of being deformedwhile remaining attached to the male boss 127, as described elsewhereherein. For example, the proximal end 127 a of the male boss 127 mayhave a polygonal or other noncircular recess therein and the outersurface of the deformable membrane 129 may have a similar shape. Thismay provide an interference fit when the deformable membrane 129 isinserted into the male boss 127, i.e., preventing rotation of thedeformable membrane 129 relative to the male boss 127. Optionally, thedeformable membrane 129 may be attached to the male boss 127 by bondingwith adhesive, sonic welding, fusing, and the like in addition to orinstead of the interference fit. The deformable membrane 129 is durableenough to resist ripping or tearing during actuation, yet strong andresilient enough to assume its original polygonal shape afterdeactuation. Similar to the elastic member 150, the deformable membrane129 may be composed of an elastomeric material, e.g., silicone, or anyother suitable material capable of performing the functions describedherein.

FIGS. 4A and 4B show the shaft 130, which includes a conduit or tubularbody 132 including first and second ends 132 a, 132 b, a throughbore 133(shown in FIG. 4B) extending therebetween, a mating member 134 with camfeatures 135, pegs 131, and a fluid post 136 with one or more sideopenings 137 on the first end 132 a. Optionally, the second end 132 bmay include one or more connectors (not shown), a length of tubing, andthe like. As shown in FIG. 4B, the second end 132 b includes an enlargedrecess 139, which may be sized for receiving an end 172 of a section oftubing 170 (not shown, see FIG. 1B). The tubing 170 may be substantiallypermanently or removably received in the recess 139, e.g., using aninterference fit, one or more mating connectors (not shown), bondingwith adhesive, sonic welding, and the like. The shaft 130 and the matingmember 134, together with their respective components may besubstantially permanently connected to one another, e.g., by integrallymolding the shaft 130, the mating member 134, and pegs 133 from a singlepiece, or by forming the components separately and attaching themtogether, e.g., by interference fit, mating connectors, bonding withadhesive, sonic welding, and the like.

Also shown in FIG. 4A is the elastic member 150, which is the same aselastic member 150 shown in FIG. 3, but here it is shown with the pegs131 disposed adjacent to and/or between the spokes 153. Thus, theelastic member 150 resides both around the shaft 130, e.g., above theproximal surface of the mating member 134, and on the distal undersideof the outer mating surface 128 (not shown, see FIG. 3), e.g., when theshaft 130 is inserted into the covering body 120 (e.g., before or afterinserting the covering body 120 into the outer shell 110), e.g., forelastically coupling the covering body 120 with the shaft 130. FIG. 4Balso shows the throughbore 133 extending through the length of theconduit 132, which extends almost the entire length of the shaft 130.The fluid post 136 resides at the proximal end of the conduit 132 andthe opening(s) 137 communicate with the throughbore 133. The fluid post136 has a corresponding polygonal shape that matches the inside opening129 a of the deformable membrane 129 (not shown, see, e.g., FIG. 6C).The polygonal shape used for the fluid post 136 is shown as a pentagon,but alternatively, any other geometric shape as described above for theouter mating surface 128 may be used for both the fluid post 136 and theopening 129 a in the deformable membrane 129.

The outer mating member 134 is shown located near the midpoint of theconduit 132. The mating member 134 may be positioned along the externalsurface of the conduit 132 so that when the shaft 130 is inserted intothe covering body 120, as shown in FIGS. 1A and 1B, the distal side ofthe outer mating surface 128 makes contact with the proximal side of themating member 134. In this position, the recesses 121 and pegs 131 holdthe elastic member 150 in the star-shape, as shown in FIGS. 3 and 4A.The star-shape assumes five recesses 121 on the covering body 120 andfive pegs on the mating member 134, as well as five spokes 153 and hubs151 on the elastic member 150 due to the pentagonal shape shown, but thenumber of recesses and pegs. Thus the shape of the elastic member 150may be changed, e.g., to correspond with the selected polygonal shapeused for the outer mating surface 128 and its matching components.

The pegs 131 are attached to and/or otherwise extend from the proximalside of the mating member 134, as shown in FIG. 4A. The pegs 131 maycouple rotational motion of the annular base 152 of the elastic member150 to rotation of the shaft 130.

Triangular indentations or cam features 135 are located on the distalside of the mating member 134. These cam features 135 may mate withtriangular projections, splines or other mating cam elements 145 locatedon the backing member 140 shown in FIG. 5 in order to effect actuation.The angle of each hypotenuse of these cam components (e.g., cam features135 and cam elements 145) may be changed to correspond to the selectedpolygonal shape of the fluid post 136 in order to maximize fluid flowupon actuation of the assembly 100. Also, the size and depth of the camfeatures 135 may be changed with the polygonal shape of the fluid cap136 to successfully effect or maximize actuation flow. The relationshipof the sizes and hypotenuse angles are further described below.

FIG. 5 shows the backing member 140, which includes the cam elements145, a proximal, relatively small end segment 144, a distal, relativelylarge end segment 146, and a throughbore 142. The cam elements 145 areattached to and/or otherwise extend from the proximal side of theproximal end segment 144 and are designed to mate with the cam features135 shown in FIG. 4A, e.g., when the covering body 120 is directedtowards the backing member 140 during actuation, as explained elsewhereherein. Generally, the cam elements 145 and cam features 135 includeramped or angled surfaces 145 a, 135 a that interact to cause rotationalmotion of the shaft 130 relative to the backing member 140 in responseto axial movement of the covering body 120 (or vice versa), as explainedelsewhere herein. The proximal end segment 144 has a correspondingpolygonal shape and size such that it matches the shape and size of thedistal throughbore 118 of outer shell 110. Thus, the proximal endsegment 144 may be received within the distal throughbore 118, therebycoupling rotation of the outer shell 110 to the backing member 140. Theproximal end segment 144 (or other features of the backing member 140)may be substantially permanently attached to the outer shell 110, e.g.,using an interference fit, one or more mating connectors (not shown),bonding with adhesive, sonic welding, and the like. It will also beappreciated that other interlocking features and/or shapes may beprovided for coupling the outer shell 110 to the backing member 140.

The distal end segment 146 of the backing member 140 has an outersurface that has substantially the same polygonal shape and size of theouter surface 111 of the outer shell 110 in order for it to fit againstthe distal end 113 of the outer shell 110, e.g., to provide a continuousouter surface for the assembly 100. The throughbore 142 may be circularand/or have the same or substantially the same diameter and/or shape asthe conduit 132 of the shaft 130.

FIGS. 6A-6H show the assembly 100 of the covering body 120, shaft 130,backing member 140, and elastic member 150. The outer shell 110 is shownin FIGS. 6A(1) and 6D(1), but has been excluded from FIGS. 6A(2) and6D(2) for simplicity, e.g., to show the inner workings of the assembly100. During manufacturing, the various components of the assembly 100may be formed, e.g., by injection molding, machining, forming, and thelike. The components may be formed from metal, plastic, and/or compositematerials, as desired. Once the components are made, they may beassembled into the assembly 100.

In an exemplary method, the annular base 152 of the elastic member 150may advanced over the fluid cap 136 onto the shaft 130, e.g., until thespokes 153 are disposed between the pegs 131. The shaft 130 may then beinserted into the covering body 120, e.g., until the hubs 151 of theelastic member are received in the recesses 121 in the outer matingsurface 128. The deformable membrane 129 may be inserted into the maleboss 127 of the covering body 120. The covering body 120 may then beinserted into the distal end 113 of the outer shell 110, e.g., afteraligning the outer mating surface 128 with the distal throughbore 118 ofthe outer shell 110. The backing member 140 may then be connected to theouter shell 140 to close the distal throughbore 118. The backing member140 may be substantially permanently attached to the outer shell 110,e.g., using cooperating connectors, bonding with adhesive, sonicwelding, fusing, and the like.

Optionally, a section of tubing 170 may be attached to the shaft 130,e.g., through the backing member 140. Alternatively, a portion of theshaft 130 (not shown) may extend through the backing member 140, e.g.,terminating in a connector (not shown), to allow a section of tubing orother device (also not shown) to be attached to the shaft 130. Theresulting assembly 100 provides a covering body or inner housing 120contained within the outer shell 110 and backing member or cover 140such that the male boss 127 is disposed adjacent the Luer thread 114 inthe outer shell 110. The covering body 120 may be movable axially, e.g.,when the male boss 127 is contacted and pushed axially into the outershell 110. The shaft 130 may be free to rotate within the assembly 100,e.g., limited by the interaction of the cam features 135 and camelements 145 as described further below.

During use, as shown in FIGS. 6A-6H, a female Luer fitting 160 may beconnected to the Luer thread 114 in the outer shell 110. The female Luerfitting 160 may be connected to a length of tubing, piece of equipment,container, and the like (not shown), which may be part of the IV orfluid line to which the assembly 100 is to be connected. The outer shell110 (not shown) has the inner thread from male Luer 116 into which thefemale Luer fitting 160 may be threaded.

Initially, in the deactuated condition shown in FIGS. 6A(1) and 6A(2),the covering body 120 is biased away from the backing member 140. Thisis due to the securing of the hubs 151 of the elastic member 150 in therecesses 121 and the position of the pegs 131, as best seen in FIGS. 6Band 6G. Although the angled surfaces 135 a, 145 a of the cam features135 and cam elements 145 may contact one another, the elastic member 150may bias the shaft to slide up the surfaces 135 a, 145 a, i.e., awayfrom the backing member 140 and towards the male Luer thread 114 on theouter shell 110. In this deactuated condition, the deactuated statusindicators 125 may be aligned axially with the status windows 112.

As the female Luer fitting 160 threads into the outer shell 110, itcontacts the male boss 127. Due to the tapered design of the male boss127, the female Luer fitting 160 pushes the covering body 120 axiallytowards the distal end 113 of the outer shell 110, thereby directing theshaft 130 within the covering body 120 also to be directing axiallytowards the backing member 140. As the covering body 120 is pushedtowards the backing member 140 by the female Luer fitting 160 contactingthe male boss 127, the mating member 134 and shaft 130 are pushed alongwith the covering body 120. As the covering body 120 is directedaxially, as best seen in FIG. 6D(1), the actuated status indicators 126become aligned with and can be seen through the status windows 112.

The resulting axial movement of the shaft 130 causes the cam features135 to interact with the cam elements 145 to rotate the shaft 130relative to the backing member 140 and, consequently, the outer shell110 and covering body 120. More specifically, the ramped surfaces 135 aof the cam features 135 slide along the ramped surfaces 145 a of the camelements 145, thereby translating the axial movement of the coveringbody 120 into axial and rotational movement of the shaft 130. Theproximal tips of the cam elements 145 are lined up with the slopingcorners of each hypotenuse of the cam features 135 before actuation, asshown in FIG. 6A(2). As the shaft 130 is pushed distally, the camfeatures 135 are forced to mate with the cam elements 145, which forcesthe mating member 134 along with the rest of the shaft 130 to rotate.

As the shaft 130 rotates, the fluid cap 136 rotates inside the opening129 a in the deformable membrane 129. Before rotation, the polygonalshape of the fluid cap 136 is matched up with the polygonal shape of theopening 129 a in the deformable membrane 129, thereby providing asubstantially fluid-tight seal between the deformable member 129 and thefluid cap 136, i.e., sealing a fluid inside throughbore 133, as shown inFIG. 6C. Rotation of the shaft 130 causes the fluid cap 136 anddeformable membrane 129 to mismatch, thereby creating gaps 129 b betweenthe deformable membrane 129 and the fluid cap 136, as shown in FIG. 6F.The elasticity of the deformable member 129 allows the fluid cap 136 totwist freely within the opening 129 a. Once mismatched, gaps 129 b arecreated between the fluid cap 136 and the deformable membrane 129, andfluid inside the throughbore 133 may now flow through the gaps 129 b andinto the female Luer fitting 160. At this point, the actuated statusindicator 126 is seen through the status windows 112, as shown in FIG.6D(1).

The angle of each hypotenuse of the cam elements 145 and cam features135 are such that when the shaft 130 is rotated to the point where thecam elements 145 are mated with the cam features 135, the fluid cap 136is evenly mismatched with the deformable membrane 129. Evenlymismatched, in this sense, means that each of the points of the fluidcap 136, which is selectively shaped from the polygonal shapes mentionedabove, are in substantially the midpoint of the sides of the opening 129a in the deformable membrane 129. Thus, with the use of pentagonallyshaped members, there are five substantially equal triangular gaps 129 bformed when the assembly 100 is in the actuated condition. Each point ofthe pentagonally shaped fluid cap 136 is situated on the midpoint of thesides of the pentagonally shaped opening 129 a in the deformablemembrane 129, as best seen in FIG. 6F. Although other degrees ofdeformation may work, the described deformation of the deformablemembrane 129 may maximize the rate of fluid flow.

As the shaft 130 rotates, the spokes 153 of the elastic member 150become stretched or deformed, as shown in FIGS. 6E and 6H, e.g., storingpotential energy in the elastic member 150. The elastic member 150 isheld in this stretched state by virtue of the mating between the camfeatures 145 and the cam elements 135. When the female Luer fitting 160is disconnected, the energy stored in the spokes 153 of the elasticmember 150 on the shaft 130 is not impeded anymore, and the shaft 130 isfree to rotate back to its original position. During this deactuationprocess, the cam features 135 slide along the cam elements 145 causingthe shaft 130 to move axially away from the backing member 140 as theshaft 130 rotates. This separation allows the shaft 130 and the coveringbody 120 to reassume their original relative rotational position, andcauses the covering body 120 to move axially away from the backingmember 140. After the covering body 120 is pushed back towards theproximal end 115 of the outer shell 110 through this deactuationprocess, the status windows 112 reveal the deactuated status indicator125 once again.

Turning to FIGS. 7A-12D, another embodiment of a valve/connectorassembly 200 is shown that includes an outer shell or bezel 210 andbacking member 240, together providing an outer package or housing forthe assembly 200, a covering body or inner housing 220, a shaft, corepin, or tubular member 230, and an elastic member 250. These componentsare generally similar to the similarly identified components of theassembly 100 (with like components having their reference numbersincreased by 100 for simplicity). Unlike the assembly 100, the assembly200 also includes a gear-shaped camming element 260 that may be coupledto the outer shell 110 and backing member 240, as described furtherbelow.

With particular reference to FIG. 8, the outer shell 210 includesproximal and distal ends 215, 213, an unthreaded portion 215 adjacentthe distal end 213 with a distal throughbore 218 having an annularrecess 217 therein, and a proximal throughbore 216 including a male Luerthread 214 therein adjacent the proximal end 215. As shown, the outershell 210 has a hexagonal shaped outer surface 211, although,alternatively, the outer surface may have any other shape, similar tothe previous embodiment. The outer surface 211 may facilitate a usergripping and/or manipulating the outer shell 210, e.g., to engage and/ordisengage the male Luer thread 214 with a female Luer connector from afluid line or other device (not shown).

The distal throughbore 218 extends from the distal end 213 of the outershell 210 to intermediate location 219. The length, size, and/or shapeof the distal throughbore 218 is sufficient to accommodate at least aportion of the covering body 220 and shaft 230 therein (not shown, seeFIGS. 7A-7C). The diameter or other cross-section of the distalthroughbore 218 may be larger than the proximal throughbore 216, e.g.,to provide an abutment surface at the intermediate location 219 forlimiting proximal movement of the covering body 220 into the distalthroughbore 218, as explained further below.

The annular recess 217 may be disposed between the abutment surface atthe intermediate location 219 and the distal end 213, e.g., closer toand/or immediately adjacent the distal end 213. The annular recess 217may have a slightly larger diameter than the rest of the distalthroughbore 218, e.g., having a height and diameter substantiallysimilar to the camming element 260 so that the camming element 260 maybe captured within the annular recess 217, e.g., to prevent removal ofthe camming element 260 while allowing it to spin within the annularrecess 217. Thus, as described further below, the outer shell 210 mayrotate relative to the camming element 260 and backing member 240,without separating the outer shell 210 from the camming element 260 andbacking member 240 (but allowing the outer shell 210 to slide axiallyrelative to the backing member 240).

The dimensions of the proximal throughbore 216 and male Luer thread 214may be provided according to ISO standards for Luer connectors.Alternatively, other connectors (not shown) may be provided on theproximal end 215, if desired.

Returning to FIGS. 7B and 7C, the covering body 220 includes anelongated male boss 227 with a deformable membrane 229 attached thereto(similar to the previous embodiments), a throughbore 223, and a matingdisc 228 including a plurality of teeth or tabs 225 and one or more lipsor tabs 221. The male boss 227 may be dimensioned per ISO industrystandards, e.g., having a cylindrical shape with a tapered proximal end.The male boss 227 and mating disc 228 of the covering body 220 may beintegrally molded or otherwise formed from a single piece or may beseparate pieces substantially permanently attached to one another.

Similar to the previous embodiments, the covering body 220 may bereceived within the outer shell 210, e.g., by inserting the male boss227 through the distal throughbore 218 into the proximal throughbore216, as shown in FIGS. 7A-7C. When the male boss 227 is received in theproximal throughbore 216, the mating disc 228 may be received in thedistal throughbore 218, e.g., contacting the abutment surface at theintermediate location 219 (see FIG. 8).

The mating disc 228 may have a diameter that substantially matches thatof distal throughbore 218. The teeth 225 are attached to or otherwiseextend from the distal side of the mating disc 228 and are configured tomatch gaps 243 in the backing member 240 (see FIG. 10A), as describedfurther below. Between the teeth 225 is a recessed portion of the matingdisc 228 that includes the one or more tabs 221, which are configured tomatch and/or be received in indentation 241 of the backing member 240.As explained further below, the tabs 225 and tabs 221 may providedetents or connectors for attaching the covering body 220 to the backingmember 240. It will be appreciated that other cooperating detents orconnectors (not shown) may be provided on the covering body 220 and/orbacking member 240 for this purpose.

The throughbore 223 runs the entire length of covering body 220, e.g.,through the mating disc 228 and male boss 227. As shown, the throughbore223 is substantially circular and may have a diameter similar to theouter diameter of conduit 232 of the shaft 230 (except for theproximal-most portion, which may have a polygonal shape for receivingthe deformable membrane 229). The deformable membrane 229 may beattached to the male boss 227, e.g., inserted into the proximal portionof the throughbore 223 as shown in FIG. 7A. The deformable membrane 229may have a polygonal shaped hollow center that matches the size andshape of fluid cap 236 of the shaft 230, as described further elsewhereherein. The deformable membrane 229 may be fixedly attached to theinside of the male boss 227 such that the deformable membrane 229 cannotrotate therein, e.g., when the deformable membrane 229 is beingdeformed, similar to the previous embodiments.

Turning to FIGS. 9A and 9B, the shaft 230 generally includes a conduit232, a throughbore 233 extending between first and second ends 232 a,232 b of the conduit 232, a mating member 234 with a plurality of camfeatures 235, and a fluid cap 236 with openings 237, similar to previousembodiments. The throughbore 233 extends through conduit 232, e.g., intothe fluid cap 236. The fluid cap 236 has a polygonal shape thatsubstantially matches the opening 229 a in the deformable membrane 229,and may include one or more openings 237, e.g., on each face of itspolygonal shape, e.g., to allow fluid to flow through the openings 237after actuation of assembly 200, as described elsewhere herein.

The mating member 234 may be located near the midpoint of the conduit232. For example, the mating member 234 may be located along a length ofthe conduit 232 such that, when the shaft 230 is inserted into thecovering body 220, as shown in FIGS. 11D and 12D, a distal side of themating disc 228 may contact a proximal side of the mating member 234,e.g., to limit insertion of the shaft 230 into the covering body 220.The mating member 234 may include one or more holes or other anchorpoints 231, e.g., located on a proximal side of the mating member 234 toreceive a portion of the elastic member 250 and/or otherwise limitmovement of the elastic member 250 relative to the shaft 230.

The cam features 235 are located on the distal side of mating member234, and generally include ramped surfaces 235 a, similar to theprevious embodiments. The cam features 235 may be configured to contactand/or otherwise interact with the camming element 260, e.g., to effectactuation and/or deactuation of the assembly 200, as described elsewhereherein. Similar to the assembly 100, the angle of each hypotenuse of thecam features 235 may be changed, e.g., to correspond to the selectedpolygonal shape for the fluid cap 236 and opening 229 a, for example, tomaximize fluid flow upon actuation. Unlike the assembly 100, each camfeature 235 may also include a tooth or extension 235 b on the distalside, which is described further below.

Also shown in FIG. 9B, the elastic member 250 is shown as a coil springthat includes first and second ends 250 a, 250 b. The elastic member 250may be sized to be received around the conduit 232 of the shaft 230,e.g., above the mating member 234. As shown, the first end 250 a mayextend radially outwardly from the shaft 230, and the second end 250 bis received in the hole 231 (best seen in FIG. 9A). After assembly, thefirst end 250 a of the elastic member 250 may be captured or otherwiseengaged to the covering body 220 and/or backing member 240 to bias theshaft 230 relative to the covering body 220. Alternatively, otherelastic members may be provided, similar to the other embodimentsdescribed herein.

Turning to FIG. 10A, the backing member 240 includes a base portion 246,and an annular portion 244 extending from the base portion 246, togetherdefining a throughbore 245 for receiving the shaft 232 and/or tubing 270therein. The annular portion 244 includes a plurality of relativelynarrow gaps or slots 243 extending axially from the base portion 246,thereby dividing the annular portion 244 into fingers. In addition, theannular portion 244 includes one or more annular recesses or grooves 241disposed within the throughbore 245. For example, each finger mayinclude a recess 241, which may be shaped to receive a corresponding tab221 on the mating disc 228.

As shown, the base portion 246 includes an outer shape substantiallysimilar to the outer shell 210, e.g., to define an outer housing for theassembly 200. In contrast, the annular portion 244 has a relativelysmaller outer diameter or cross-section, e.g., similar to that of themating disc 228. As best seen in FIGS. 11C and 12C, the annular portion244 may be sized to be received in the distal throughbore 218 of theouter shell 210, as described further below.

The slots 234 are sized and/or shaped to received the teeth 225 on thecovering body 220 and/or the extensions 235 b on the camming features235. For example, during assembly, the teeth 225 on the mating disc 228may be received in respective slots 243 while the tabs 221 are receivedwithin the throughbore 245 of the annular portion 244, e.g., such thatthe tabs 221 are received in and/or otherwise engage the recesses 241,e.g., to substantially permanently attach the covering body 220 to thebacking member 240. It will be appreciated that other mating connectors(not shown) may be provided on the covering body 220 (e.g., on themating disc 228) and/or on the backing member 240 (e.g., on the annularportion 244) to substantially permanently or removably attach thecovering body 220 to the backing member 240. In addition oralternatively, the covering body 220 may be attached to the backingmember 240 by bonding with adhesive, sonic welding, fusing, and thelike.

Turning to FIG. 10B, the camming element 260 includes a plurality ofspokes 261 extending from a central hub 262 including a passage 263therethrough. The passage 263 has a diameter larger than the conduit 232of the shaft 230, e.g., to allow the conduit 232 to be slidable throughthe camming element 260. The spacing and configuration of the spokes 261may correspond to the slots 243 in the backing member 240, e.g., suchthat spokes 261 may be slidably received in the slots 243, therebyallowing the camming element 260 to slide axially relative to thebacking member 240.

In addition, the spokes 261 may be sufficiently long such that, when thecamming element 260 is inserted into the distal end 213 of the outershell 210, the spokes 261 may be snapped, captured, or otherwisereceived in the annular recess 217 such that camming element 260 issubstantially fixed axially within the outer shell 210. The outerdiameter defined by the spokes 261 may be slightly smaller than theannular recess 217, thereby allowing the camming element 260 and outershell 210 to rotate relative to each other. The width of the spokes 261may also substantially match or be slightly narrower than the height ofthe annular recess 217 in the outer shell 210.

FIGS. 11A-12D show the assembly 200, including the outer shell 210,covering body 220, shaft 230, backing member 240, elastic member 250,and camming element 260 assembled together, in a deactuated or closed(no-flow) position (FIGS. 11A-11D) and an actuated or open (flow)position.

Before use, as shown in FIGS. 7A-7C, the components of the assembly 200may be assembled together, e.g., during manufacturing. Althoughexemplary methods are described herein, it will be appreciated that theorder of the various stages or steps and/or the particular steps usedmay be changed, as desired, e.g., based upon manufacturing convenienceand/or other factors. With additional reference to FIG. 9B, the elasticmember 250 may be received around the shaft 230, e.g., around theconduit 232 above the mating member 234. The second end 250 b of theelastic member 250 may be received in the hole 231, thereby preventingsubsequent rotation of the elastic member 250 relative to the shaft 230.

The proximal end 232 a of the shaft 230 may be inserted into thecovering body 220, e.g., into the throughbore 223 through the matingdisc 228 until the fluid cap 236 is received within the opening 229 a ofthe deformable membrane 229, as best seen in FIG. 7A. During this stage,the mating member 234 of the shaft 230 may be spaced apart from themating disc 228 of the covering body 220, e.g., such that the elasticmember 250 is spaced away from the mating disc 228. Alternatively, therelative length of the male boss 227 and conduit 232 may be such thatthe mating member 234 contacts or is received within the mating disc 228(not shown). In this alternative, the covering body 220 may include aninternal axial slot or peripheral hole (not shown) for receiving thefirst end 250 a of the elastic member 250. This configuration may allowthe shaft 230 to rotate within the covering body 220 yet the elasticmember 250 may bias the shaft 230 to return to a desired rotationalposition (e.g., where the assembly 200 is closed, as explained elsewhereherein).

The covering body 220 (with the shaft 230 therein) may be inserted intothe outer shell 210, e.g., into the distal throughbore 218 until themale boss 227 enters the proximal throughbore 216 and/or the mating disc228 abuts the abutment surface at the intermediate location 219. Thecamming element 260 may be inserted over and around the distal end 232 bof the shaft 230 and into the distal throughbore 218 of the outer shell210, e.g., until the spokes 261 snap into or are otherwise captured orreceived within the annular recess 217.

The backing member 240 may be inserted into the distal end 213 of theouter shell 210, e.g., around the shaft 230 and camming element 260.This may involve aligning the slots 233 in the annular portion 244 ofthe backing member 240 with the spokes 261 on the camming element 260.The backing member 240 may be advanced until the annular portion 244 isconnected to the mating disc 228 on the covering body 220. Thisconnection may also require rotating the backing member 240 to ensurethat the teeth 225 on the mating disc 228 are aligned with the slots 243on the annular portion 244 and the tabs 221 enter the throughbore 245 ofthe annular portion 244, e.g., to engage the tabs 221 with the recesses241.

If the assembly 200 is to be connected to tubing 170 (or anothercontainer or device, not shown), the end 172 of the tubing 170 may beconnected to a connector on the distal end 232 b of the shaft 230.

In an alternative procedure, the camming element 260 may be insertedinto the throughbore 245 of the annular portion 244 of the backingmember 240, i.e., after aligning the spokes 261 with the slots 243. Thecovering body 220, with the shaft 230 and elastic member 250 therein,may then be attached to the annular portion 244, e.g., by aligning theteeth 255, tabs 221, slots 243 and recesses 241, as described elsewhereherein. During this step, the first end 250 a of the elastic member 250may be received in one of the slots 243 in the annular portion 244. Theouter shell 210 may then be received over this subassembly, e.g., byinserting the male boss 227 into the distal throughbore 218 of the outershell 210 until the camming element 260 is captured in the annularrecess 217.

During use, the assembly 200 may be provided as shown in FIGS. 7A and11A-11D. In this condition, a fluid path through the assembly 200 may bebiased to a closed position, e.g., with the shaft 230 in a rotationalposition such that the fluid cap 236 is aligned with and received in theopening 229 a of the deformable membrane 229, as best seen in FIG. 7A.The outer shell 210 may be freely rotated relative to the backing member240 and the internal components of the assembly 200. This may facilitaterotating the outer shell 210 to attach the assembly 200 to a fluid lineor other device (not shown).

The outer shell 210 may also be free to move axially, although the axialmovement is limited by the movement of the camming element 260 axiallywithin the annular portion 244 of the backing member 240. For example,the outer shell 210 may be directed distally until the camming member260 and/or outer shell 210 contacts the base portion 246. In this distalposition, the male boss 227 may extend to and/or partially out of theproximal end 215 of the outer shell 210, e.g., similar to a conventionalmale Luer connector. This position may facilitate cleaning the male boss227, fluid cap 236, and/or deformable membrane 229, e.g., during use. Inaddition, the outer shell 210 may be directed proximally away from thebase portion 246 of the backing member 240 until the camming element 260contacts the cam features 235 on the mating member 234 of the shaft 230.

Turning to FIG. 11A, a female Luer 160 is shown, which includes anexternal Luer thread that is partially inserted into the proximal end215 of the outer shell 210. In this position, the outer shell 210 mayremain movable axially some distance relative to the backing member 240.

Turning to FIGS. 12A-12D, as a female Luer connector 160 is fullythreaded into the outer shell 210, it pushes the male boss 227 towardthe distal end 213 of the outer shell 210. This causes the covering body220 and shaft 230 to move toward the distal end 213 of the outer shell210. Stated differently, as the female Luer 160 is threaded into theproximal end 215 of the outer shell 210, the outer shell 210 may bepulled proximally away from the male boss 227 and the base portion 246of the backing member 240, thereby moving the camming element 260 awayfrom the base portion 246 and towards the mating member 234 on the shaft230.

This causes the camming element 260 to contact the cam features 235 onthe shaft 230, i.e., the cam features 235 are pushed against the spokes261 of the camming element 260, which causes the shaft 230 to rotate.The angle of each hypotenuse and size of cam features 235 may be suchthat, when the shaft 230 is rotated to the point where the spokes 261bottom out and abut vertical walls 235 c adjacent the cam features 235.In this position, the fluid cap 236 is mismatched with the deformablemembrane 229, i.e., the fluid cap 236 has rotated relative to theopening 229 a to create gaps 229 b between the fluid cap 236 and thedeformable membrane 229. The gaps 229 b open a fluid path between thethroughbore 233 in the shaft 230 and the proximal throughbore 216 of theouter shell 210, i.e., into the Luer fitting 160 attached to theassembly 200. Thus, the fluid path may be opened substantiallysimultaneously with threading the female Luer connector 160 into theassembly 200.

For example, the fluid cap 236 may be substantially evenly mismatchedwith the deformable membrane 229, i.e., such that each of the points ofthe fluid cap 236 are in substantially the midpoint of the sides of theopening 229 a in the deformable membrane 229. As shown in FIGS. 11B and12B, for example, using hexagonally shaped members, there are six equalsubstantially triangular gaps 229 b formed between the fluid cap 236 andthe deformable membrane 229 when the assembly 200 is in the actuatedstate, i.e., because each point of the hexagonally shaped fluid cap 236is situated on the midpoint of the sides of the hexagonally shapedopening 229 a in the deformable membrane 229. Although other degrees ofdeformation may work, the described deformation of the deformablemembrane may maximize the rate of fluid flow.

In addition, when the female Luer connector 160 is tightened into theproximal end 215 of the outer shell 210, a region 226 of the annularportion 244 of the backing member 240 may become exposed. If desired, anactuated status indicator 226 may be provided on the annular portion244, as shown in FIG. 12A, which may become exposed only when the femaleLuer connector 160 is finally tightened to the outer shell 210. Thestatus indicator 226 may include a color (such as green), one or morewords, and the like, similar to other embodiments herein, which mayprovide the user visual confirmation that the assembly 200 has achievedthe actuated position in which the flow path is open. Optionally, theregion between the actuated status indicator 226 and the base portion240 may include another status indicator (not shown), such as acontrasting color (e.g., red), which may provide a visual indication tothe user that the assembly 200 has not yet been actuated.

Turning to FIGS. 13A-16B, yet another exemplary embodiment of avalve/connector assembly 300 is shown that includes the same generalcomponents as the assembly 200. Since the corresponding structures ofthe assembly 300 function in the same manner as described above for theassemblies 100, 200, like components have been similarly numbered(except preceded by 300, rather than 100 or 200. As best seen in FIGS.14A and 14B, the assembly 300 includes an outer shell 310 with a femaleLuer thread 314, a covering body or inner housing 320 with a deformablemembrane 329, a shaft or core pin 330 with an elastic member, i.e.,spring 350, and a backing member 340, generally similar to the apparatus200. The outer shell 310 is structurally distinct from the outer shell210 in assembly 200, and includes a proximal throughbore 316, anunthreaded portion 315, a tapered portion 317, a distal throughbore 318,and a female Luer thread 314.

Generally, the components, assembly, use, and operation of the assembly300 is similar to the previous embodiments. Unlike the previousembodiments, however, the outer shell 300 includes a female Luerconnector and thread 314 for mating with a male Luer connector 160′(shown in FIGS. 15A and 15B), e.g., communicating with a fluid line orother device (not shown).

Turning to FIGS. 17A-23C, still another exemplary embodiment of avalve/connector assembly 400 is shown that includes an outer shell 410,a covering body or inner housing 420, a shaft, core pin, or tubularmember 430, a backing member 440, an elastic member 450, and a cammingelement 460. Generally, the components, assembly, use, and operation ofthe assembly 400 is similar to the previous embodiments.

Unlike the previous embodiments, the covering body 420 includes a closedcap including a plurality of openings 429 in the side thereof. Inaddition, the shaft 430 includes a closed proximal end 432 a including aplurality of openings 437 in a side wall thereof. The elastic member 450includes a compression member, such as one or more spring washers, whichmay bias the covering body 420 into the proximal end 415 of the outershell 410. It will be appreciated that these versions of the coveringbody 420/shaft 430 or elastic member 450 may be utilized in otherembodiments disclosed herein or may be replaced with similar componentsfrom the other embodiments herein.

In addition, the shaft 430 includes a distal end 432 b that has anoncircular cross-section, e.g., a polygonal shape, similar to a passagethrough the elastic member 460. The camming element 460 includes one ormore helical ridges that are shaped similar to helical grooves in themating member 428 of the covering body 420. It will be appreciated thatother mating helical features may be provided on or in the cammingelement 460 and covering body 420, e.g., to provide a camming mechanismthat translates relative axial movement between the covering body 420and the shaft 430 into rotational motion.

Turning to FIGS. 22A-22D, the assembly 400 is shown in the closedposition in which the openings 437, 429 in the shaft 430 and coveringbody 420 are out of alignment with one another, thereby closing a fluidpath between the throughbore in the shaft 430 and the proximal end 415of the outer shell 410.

Turning to FIGS. 23A-23D, when a connector, e.g., a female Luer fitting160, is connected to the proximal end 415 of the outer shell 410, thecovering body 420 is directed distally towards the backing member 440.This causes the camming element 460 and, consequently, the shaft 430 torotate relative to the covering body 420 due to the interaction of thehelical camming features, thereby aligning the openings 437, 429 andopening the fluid path through the assembly 400.

When the covering body 420 is directed distally, the elastic member 450may be compressed, as shown in FIG. 23B. When the connector 160 isdisconnected from the assembly 410, the elastic member 450 mayresiliently expand, thereby biasing the covering body 420 to moveproximally away from the backing member 440, and causing the shaft 430to rotate to automatically close the fluid path through the assembly400. Thus, unlike the previous embodiments, the fluid path may not beopened until immediately before threading is completed. Stateddifferently, the female Luer fitting 160 may become engaged with theproximal end 415 before the assembly 400 is actuated, i.e., before thefluid path is opened. After use, when the assembly 400 is beingdisengaged from the female Luer fitting 160, the assembly 400 may becomedeactuated, i.e., the fluid path may be closed, immediately uponbeginning disengagement, thereby reducing the risk of fluid leakage fromthe assembly 400.

Turning to FIGS. 24A-32B, yet another exemplary embodiment of avalve/connector assembly 500 is shown that includes the same generalcomponents as the previous assemblies. As best seen in FIGS. 24A-24C,the assembly 500 includes an outer shell or bezel 510 with a male Luerthread 514, a covering body or inner housing 520, a shaft or core pin530, a spring or other elastic member 550, and a backing member 540.

With particular reference to FIG. 25, the outer shell 510 includesproximal and distal ends 515, 513, a distal throughbore 518 having anannular recess 517 therein, and a proximal throughbore 516 including themale Luer thread 514 therein adjacent the proximal end 515. As shown,the outer shell 510 has a hexagonal shaped outer surface 511, although,alternatively, the outer surface may have any other shape, similar tothe previous embodiments. For example, the outer surface 511 mayfacilitate a user gripping and/or manipulating the outer shell 510,e.g., to engage and/or disengage the male Luer thread 514 with a femaleLuer connector from a fluid line or other device (not shown).

The distal throughbore 518 extends from the distal end 513 of the outershell 510 to intermediate location 519. The length, size, and/or shapeof the distal throughbore 518 is sufficient to accommodate at least aportion of the inner housing 520 and shaft 530 therein (not shown, seeFIGS. 24A-24C). The diameter or other cross-section of the distalthroughbore 518 may be larger than the proximal throughbore 516, e.g.,to provide an abutment surface at the intermediate location 519 forlimiting proximal movement of the covering body 520 into the distalthroughbore 518, as explained further below.

The annular recess 517 may be disposed between the abutment surface atthe intermediate location 519 and the distal end 513, e.g., closer toand/or immediately adjacent the distal end 513. The annular recess 517may have a slightly larger diameter than the rest of the distalthroughbore 518, e.g., having a height and diameter substantiallysimilar to tabs 548 on the backing member 540, e.g., to couple the outerhousing 510 to the backing member 540. Thus, as described further below,the outer housing 510 may be substantially fixed axially relative to thebacking member 540, but may rotate freely relative to the backing member540.

The dimensions of the proximal throughbore 516 and male Luer thread 514may be provided according to ISO standards for Luer connectors.Alternatively, other connectors (not shown) may be provided on theproximal end 515, if desired, similar to the previous embodiments.

Turning to FIGS. 26A and 26B, the inner housing 520 generally includesan elongated male boss 527, a throughbore 523, and an enlarged matingportion 528. The male boss 527 may be dimensioned per ISO industrystandards, e.g., having a cylindrical shape with a tapered proximal end.The male boss 527 and mating portion 528 of the inner housing 520 may beintegrally molded or otherwise formed from a single piece or may beseparate pieces substantially permanently attached to one another. Thethroughbore 523 runs the entire length of inner housing 520, e.g.,through the mating portion 528 and the male boss 527, e.g., all similarto the previous embodiments.

Also similar to the previous embodiments, the inner housing 520 may bereceived within the outer shell 510, e.g., by inserting the male boss527 through the distal throughbore 518 into the proximal throughbore516, as shown in FIGS. 24B and 24C. When the male boss 527 is receivedin the proximal throughbore 516, the mating portion 528 may be receivedin the distal throughbore 518, e.g., contacting the abutment surface atthe intermediate location 519 (see FIG. 29B), and the male boss 527 mayextend concentrically within the male Luer thread 514.

The mating portion 528 may have a diameter that substantially matchesthat of the distal throughbore 518, e.g., such that the mating portion528 may rotate freely within the distal throughbore 518 withoutsubstantial lateral movement. In addition, one or more helical threads,grooves, or ridges 525 may be molded, machined, or otherwise providedalong the throughbore 523 within the mating portion 528. The helicalridges 525 may correspond to similar helical ridges or grooves 545 onthe backing member 540, as described further below. It will beappreciated that other ridges, grooves, and/or other features (notshown) may be provided on the mating portion 528 and the backing member540, i.e., to provide cooperating helical features between the matingportion 528 and the backing member 540. In addition or alternatively,any number of cooperating threads or features, e.g., one or more, may beprovided on the mating portion 528 and backing member 540 to allow themating portion 528 to move helically relative to the backing member 540,as described further below.

In addition, as best seen in FIGS. 26B, 29C, 31B, and 32B, the matingportion 528 includes one or more partial circumferential ledges 524disposed between the helical ridges 525 and the male boss 527. Forexample, the mating portion 528 may include three circumferential ledges524 extending partially around the inside surface of the mating portion528 that are spaced apart from one another, e.g., each ledge 524extending less than a third the distance around the circumference.

As best seen in FIGS. 26B, 31B, and 32B, in the gap between adjacentcircumferential ledges 524, the mating portion 528 may include rampedtabs or ledges 522. Each ramped tab 522 includes a ramped surface 522 aextending distally towards the helical ridges 525 and ending in a bluntdistal surface 522 b. The ramped tabs 522 may be offset axially, e.g.,proximally, from the circumferential ledges 524, as explained furtherbelow.

The male boss 527 may include a seal 529 disposed within the throughbore523, e.g., at the proximal end 527 a of the male boss 527 forselectively sealing the assembly 500, as described further below. Forexample, as shown in FIGS. 26B and 29C, the seal 529 may include acentral sealing pin 529 a supported by one or more supports 529 bextending radially inwardly from the proximal end 527 a of the male boss527. As shown, three supports 529 b may be disposed radially around thesealing pin 529 a, thereby defining three openings 529 c through whichfluid may flow, as described further below. The sealing pin 529 a mayhave a conical shape, as shown, or, alternatively, a frusto-conical orother shape (not shown) for sealing a throughbore 533 through the shaft530, as described further below.

Turning to FIGS. 27A and 27B, the shaft 530 generally includes a conduit532, the throughbore 533 extending between first and second ends 532 a,532 b of the conduit 532, and a mating member 534 with a plurality ofcam features 535. The mating member 534 may be located near the midpointof the conduit 532. For example, the mating member 534 may be locatedalong a length of the conduit 532 such that, when the shaft 530 isinserted into the inner housing 520, the mating member 534 is disposedproximal to the circumferential ledges 524 on the inner housing 520,i.e., between the circumferential ledges 524 and the male boss 527,e.g., as shown in FIGS. 29B and 29C.

The cam features 535 may extend radially or otherwise from the matingmember 534, and generally include proximal ramped surfaces 535 aextending to blunt pockets 535 b. The ramped surfaces 525 a may beconfigured to contact and/or otherwise interact with the ramped tabs 522on the inner housing 520, e.g., to effect actuation and/or deactuationof the assembly 500, as described elsewhere herein. Similar to theprevious assemblies, the angle of ramped surfaces of the cam features525 and ramped tabs 522 may be changed, e.g., to correspond to theselected configuration, e.g., number and/or orientation ofcircumferential ledges 524, ramped tabs 522, and cam features 535, forexample, to maximize fluid flow upon actuation.

Optionally, as shown in FIGS. 27A and 29C, the proximal end 532 a of theconduit 532 may have a tapered inner surface, e.g., corresponding to theshape of the sealing pin 529 a. Thus, when the shaft 532 is fullyreceived in the inner housing 520, e.g., such that the mating member 534is disposed proximal to the circumference ledges 524, the proximal end532 a of the conduit 532 may abut and/or otherwise engage the sealingpin 529, thereby substantially sealing the throughbore 533 through theconduit 532. During use, the proximal end 532 a of the conduit 532 maybe directed away from the sealing pin 529 a to open the throughbore 533,as described further below.

As best seen in FIG. 27B, the distal end 532 b of the conduit 532 mayhave a noncircular cross-section, e.g., a hexagonal or other polygonalshape. In addition, the distal end 532 b may include one or more visualindicators 526, e.g., for indicating when the assembly 500 is actuated(and/or deactuated), similar to previous embodiments and/or as describedfurther below. In addition or alternatively, the distal end 532 b mayinclude a nipple or other connector 532 c, e.g., for connecting theassembly to tubing or other fluid line 170, as shown in FIGS. 29B and30B.

Turning to FIGS. 28A-28C, the backing member 540 includes a relativelywide base portion 546, and a relatively narrow annular portion 544extending proximally from the base portion 546, together defining athroughbore 542. The throughbore 542 may include a relatively largeproximal passage 542 a through the annular portion 544 (best seen inFIG. 28B) and a relatively narrow distal passage 542 b through the baseportion 546 (best seen in FIG. 28C). The distal passage 542 b may have anoncircular, e.g., hexagonal or other polygonal, shape similar to thedistal end 532 b of the conduit 532 such that the conduit 532 may befree to pass axially through the distal passage 542 b without rotatingrelative to the backing member 540.

The backing member 540 also includes one or more helical ridges and/orgrooves 545, e.g., extending helically along an outer surface of theannular portion 544, e.g., for cooperating with the helical ridges 525on the inner housing 520, as described further below. In addition, thebacking member 540 may includes one or more tabs or other connectors548, e.g., for coupling the backing member 540 to the outer shell 510.As best seen in FIGS. 28A-28C, the tabs 548 may include cantileverelements having one end 548 a fixed to the backing member 540, e.g., tothe annular portion 544, and radial elements including ramped proximaledges 548 b and blunt distal edges 548 c.

During assembly, the tabs 548 may be deflected radially inwardly. e.g.,to define a size no larger than the annular portion 544, yet biasedoutwardly to define a size larger than the base portion 546. The annularportion 544 may have a diameter or other cross-section such that theannular portion 544 may be received within the distal throughbore 518 inthe outer shell 510, as described further below.

Also shown in FIG. 28C, the proximal passage 542 b may be sized toreceive the elastic member 550 therein. The elastic member 550 may be acompression spring having a diameter smaller than the proximal passage542 b but larger than the distal passage 542 a such that a first ordistal end of the spring 550 abuts the base portion 546 of the backingmember 540 when the spring 550 is inserted into the proximal passage 542b. The inner diameter of the spring 550 may be sized to be receivedaround the conduit 532 of the shaft 530, as shown in FIGS. 29B, 30B,31A, and 32A. As best seen in FIGS. 31A and 32A, a second or proximalend of the spring 550 may be smaller than the mating member 534 of theshaft 530 such that the proximal end of the spring 550 abuts and/orpushes against the mating member 534. Thus, the spring 550 may bias theshaft 530 away from the backing member 540, as described further below.

With reference to FIGS. 24A-24C, during manufacturing, the components ofthe assembly 500 may be formed and assembled together. Althoughexemplary methods are described herein, it will be appreciated that theorder of the various stages or steps and/or the particular steps usedmay be changed, as desired, e.g., based upon manufacturing convenienceand/or other factors. For example, the outer shell 510, inner housing520, shaft 530, and backing member 550 may be molded, machined, orotherwise formed separately from one another, e.g., from plastic, metal,or composite material, similar to the previous embodiments.

The spring 550 may be received around the shaft 530, e.g., inserted overthe distal end 532 b of the conduit 532. The distal end 532 b of theconduit 532 may then be inserted into the annular portion 544 of thebacking member 540, e.g., through the throughbore 542, which may requirealigning the distal end 532 b with the distal passage 542 a. The spring550 may then be received in the proximal passage 542 b within theannular portion 544 of the backing member 540. Thereafter, the shaft 530may be movable axially relative to the backing member 540 butrotationally fixed relative to one another. For example, the shaft 530may be directed distally into the backing member 540 with the spring 550biasing the shaft 530 to return proximally away from the backing member540.

Before or after inserting the shaft 530 through the backing member 540,the proximal end 532 a of the shaft 530 may be inserted into the innerhousing 520. For example, the proximal end 532 a may be inserted intothe throughbore 523 through the mating portion 528 until the matingmember 534 passes the circumferential ledges 524. This may requirealigning the ramped tabs 535 with the gaps between the circumferentialledges 524 to and twisting the shaft 530 to pass the cam features 535between the tabs 522 and the ledges 524. Once the shaft 530 is fullyseated in the inner housing 520, the proximal end 532 a of the conduit532 may engage the seal 529 on the male boss 527 of the inner housing520, thereby substantially sealing the throughbore 533 of the conduit532 from fluid flow therethrough.

If the shaft 530 has already been received through the backing member540, the helical ridges 525, 545 on the inner housing 520 and backingmember 540 should be aligned before fully seating the shaft within theinner housing 520, i.e., to allow the inner housing 520 to movehelically relative to the backing member 540. Similarly, if the backingmember 540 is advanced over the distal end 532 b of the shaft 530 afterreceiving the shaft 530 within the inner housing 520, the helical ridges525, 545 should still be aligned during advancement.

The inner housing 520 (with the shaft 530 therein) may be inserted intothe outer shell 510, e.g., into the distal throughbore 518 until themale boss 527 enters the proximal throughbore 516 and/or the matingportion 5 abuts the abutment surface at the intermediate location 519.

The backing member 540 may then be connected to the outer shell 510,e.g., to capture the inner housing 520, shaft 530, and spring 550 withinthe outer shell 510. For example, the annular portion 544 of the backingmember 540 may be inserted into the distal throughbore 518 of the outershell 510 until the tabs 548 contact the distal end 513 of the outershell 510. Further insertion of the backing member 540 causes the rampedsurfaces 548 b of the tabs 548 to contact the distal end 513, therebydirecting the tabs 548 inwardly and allowing the tabs 548 to enter thedistal throughbore 518. Once the tabs 548 reach the annular recess 517,the tabs 548 may be free to return radially outwardly and enter theannular recess 517. The blunt distal edges 548 c prevent the backingmember 540 form being disconnected from the outer shell 510. Thus, theouter shell 510 and backing member 540 may be fixed axially relative toone another, yet the outer shell 510 may be free to rotate relative tothe backing member 540, e.g., such that the tabs 548 slidecircumferentially within the annular recess 517.

If the assembly 500 is to be connected to tubing 170 (or anothercontainer or device, not shown), the end 172 of the tubing 170 may beconnected to the connector 532 c on the distal end 532 b of the shaft530, e.g., as shown in FIGS. 29B and 30B.

During use, the assembly 500 may be provided as shown in FIGS. 29A-29Cand 31A-31B. In this condition, the assembly 500 may be in a closedposition, e.g., with the shaft 530 in an axial position such that theproximal end 532 a of the conduit 532 is substantially sealed by theseal 529 on the inner housing 520, e.g., as best seen in FIG. 29C. Theouter shell 510 may freely rotate relative to the backing member 540 andthe internal components of the assembly 500, e.g., the inner housing 520and shaft 530. This may facilitate rotating the outer shell 510 toattach the assembly 500 to a fluid line or other device (not shown).

In the closed position, the mating member 534 of the shaft 530 isdisposed between the circumferential ledges 524 and male boss 527 on theinner housing 520, as best seen in FIGS. 29C and 31B, thereby couplingaxial movement of the shaft 530 to the inner housing 520. Thus, if theinner housing 520 is directed axially relative to the outer shell 510,the shaft 530 is also initially directed axially.

Turning to FIGS. 30A-30C and 31A-31B, a female Luer 160 is shown fullythreaded into the outer shell 510. When the female Luer 160 is initiallythreaded into the outer shell 510, the female Luer 160 may contact themale boss 527 on the inner housing 520. Once the female Luer 160 isfully engaged with the male boss 527, further threading of the femaleLuer 160 causes the inner housing 520 to move distally relative to theouter shell 510 and the backing member 540. Because the inner housing520 is coupled to the backing member 540 by helical threads 525, 545,distal movement of the inner housing 520 also causes the inner housingto rotate, i.e., move helically distally relative to the backing member540. Because the shaft 530 is fixed rotationally relative to the backingmember 540, this means that the inner housing 530 also rotates relativeto the shaft 530, but also directs the shaft 530 distally relative tothe backing member 540. Thus, during this initial movement, the proximalend 532 a of the shaft 530 remains sealed by the seal 529 on the maleboss 527.

With reference to FIGS. 31B and 32B, as the inner housing 520 rotatesrelative to the shaft 530, the ramped tabs 522 approach the cam features535 and the cam features 535 slide along the circumferential ledges 524towards the gaps between the adjacent ledges 524. In the final stage ofthreading the female Luer 160 into the outer shell 510, the ramped tabs522 contact the cam features 535, i.e., the ramped surfaces 522, 535 aslidably engage one another. This causes the shaft 530 to move distallyrelative to the inner housing 520 directing the cam features 535 intothe gaps between the ledges 524. This causes the proximal end 532 a ofthe shaft 530 to move distally away from the sealing pin 529 a, as bestseen in FIG. 30C, thereby opening the fluid path through the assembly500, i.e., through the throughbore 533 of the shaft 530.

Once the tabs 522 pass over the cam features 535, the blunt distalsurfaces 522 b of the ramped tabs 522 enter the pockets 535 b, therebylocking the assembly 500 in the open position. In addition oralternatively, the cam features 535 may abut the sides of thecircumferential ledges 524, thereby preventing further rotational motionof the inner housing 520 relative to the shaft 530. At this point, thefemale Luer 160 is fully threaded into the outer shell 510. Thus, unlikeprevious embodiments, the fluid path through the assembly 500 may not beopened until the female Luer 160 is substantially fully threaded intothe proximal end 515 of the outer shell 510. This configuration mayreduce the risk of fluid leakage during connection or disconnection ofthe assembly 500 to or from a fluid line. Stated differently, theassembly 500 may be engaged before the assembly 500 is actuated, i.e.,the fluid path is opened. In addition, the assembly 500 may provide alock that substantially secures the assembly 500 in the actuatedcondition until the user affirmatively decides to deactuate the assembly500.

In addition, as best seen in FIG. 30A, when the female Luer connector160 is tightened into the proximal end 515 of the outer shell 510,thereby causing the shaft 530 to be directed distally, one or moreactuated status indicators 526 may become exposed below the backingmember 540. The status indicator(s) 526 may include a color (such asgreen), one or more words, and the like, similar to other embodimentsherein, which may provide the user visual confirmation that the assembly500 has achieved the actuated position in which the flow path is open.In addition, the blunt ends 522 b of the tabs 522 entering the pockets535 b of the cam features 535 may also provide a tactile indication tothe user that the assembly 500 has been successfully actuated. Inaddition or alternatively, the tabs 522 may generate a “click” or otheraudible sound as they enter the pockets 535 b, providing furtherconfirmation to the user.

When it is desired to disconnect the assembly 500 and/or close the fluidpath, the female Luer 160 may be unthreaded from the outer shell 510.This causes the inner housing 520 to rotate relative to the shaft 530,thereby removing the tabs 522 from the pockets 535 b. As soon as thetabs 522 are disengaged from the pockets 535 b, the spring 550 may biasthe shaft 530 to move proximally, thereby causing the ramped surfaces522 a, 535 a to again slide relative to one another and direct themating member 534 back over the circumferential ledges 524. Thus, as thefemale Luer 160 begins to move proximally during unthreading, the shaft530 may immediately move proximally relative to the inner housing 520,thereby reengaging the proximal end 532 a of the shaft 530 with thesealing pin 529 a on the inner housing 520. This action therefore closesthe fluid path at the beginning of unthreading of the female Luer 160,thereby minimizing fluid leakage during disconnection. Thus, theassembly 500 may be deactuated immediately, while the assembly 500 isstill engaged to the female Luer fitting 160. Thereafter, the femaleLuer fitting 160 may be unthreaded from the assembly 500 withoutsubstantial risk of fluid leakage.

Turning to FIGS. 45A-50B, yet another embodiment of a valve/connectorassembly 600 is shown that includes similar general components as theprevious assemblies. As shown in FIGS. 45A-45C, the assembly 600includes an outer shell or bezel 610 with a male Luer thread 614, acovering body or inner housing 620, and a spring or other elastic member650 disposed between a backing member 640 and a camming element 660.Unlike the previous embodiments, a length of tubing 630 is used insteadof a separate shaft within the assembly 600, although alternatively, thecamming element 660 may be incorporated into a shaft (not shown),similar to the previous embodiments. The components of the assembly 600are aligned generally along a central axis 602, e.g., such that one ormore of the components may move axially and/or rotationally relative tothe axis 602, as described further below.

Similar to the previous embodiments, the outer shell 610 includesproximal and distal ends 615, 613, and a distal throughbore 618 and aproximal throughbore 616 communicating with one another. Similar to theprevious embodiments, the proximal throughbore 616 includes the maleLuer thread 614 therein adjacent the proximal end 615, althoughalternatively, a female Luer connector or other connector (not shown)may be provided on the proximal end 615 instead, if desired. As shown,the outer shell 610 has a hexagonal shaped outer surface 611 includingvertical grooves to facilitate manipulating the assembly 600, although,alternatively, the outer surface may have other shapes, similar to theprevious embodiments.

The distal throughbore 618 extends axially from the distal end 613 ofthe outer shell 610 to intermediate location 619. The length, size,and/or shape of the distal throughbore 618 is sufficient to accommodateat least a portion of the inner housing 620, camming member 660, tubing630, and backing member 640 therein. The diameter or other cross-sectionof the distal throughbore 618 may be larger than the proximalthroughbore 616, e.g., to provide an abutment surface at theintermediate location 619 for limiting proximal movement of the innerhousing 620 into the distal throughbore 618, as explained further below.

A circumferential ridge 617 or one or more other connectors (not shown)may be provided on or adjacent the distal end 613, e.g., within thedistal throughbore 618. The ridge 617 may extend at least partiallyaround the distal end 613 of the outer shell 610, e.g., within thedistal throughbore 618. As shown, the ridge 617 may include separateridge portions that each extends only partially around the distal end613, along an extended portion of the outer shell 610 that are spacedapart by shortened portions of the outer shell 610. Alternatively, theridge 617 may extend entirely around the distal end 617 (not shown). Theridge 617 may have a slightly smaller diameter than the rest of thedistal throughbore 618 to engage or otherwise capture a portion of thebacking member 560, e.g., to provide a “snap” connection that couplesthe outer shell 610 to the backing member 640. For example, the ridge617 may include a ramped distal edge and a blunt proximal edge to allowthe backing member 640 to be inserted into the distal end 613 whilepreventing subsequent removal. As described further below, onceattached, the outer housing 610 may be substantially fixed relative tothe backing member 640, i.e., preventing both relative axial androtational movement of the outer housing 610 and the backing member 640,as described further below.

The dimensions of the proximal throughbore 616 and male Luer thread 614may be provided according to ISO standards for Luer connectors.Alternatively, other connectors (not shown) may be provided on theproximal end 615, if desired, similar to the previous embodiments.

As best seen in FIGS. 46B, 47B, and 49A-49D, the inner housing 620generally includes an elongated male boss 627, an enlarged matingportion 628, and a throughbore 623 extending axially therethrough. Themale boss 627 may be dimensioned per ISO industry standards, e.g.,having a cylindrical shape with a tapered proximal end. The male boss627 and mating portion 628 of the inner housing 620 may be integrallymolded or otherwise formed from a single piece or may be separate piecessubstantially permanently attached to one another. The throughbore 623runs the entire length of inner housing 620, e.g., through the matingportion 628 and the male boss 627, e.g., similar to the previousembodiments. As best seen in FIGS. 46B and 47B, the throughbore 623includes a relatively narrow portion 623 a that extends through the maleboss 627 and a relatively wider portion 623 b that extends through themating portion 628.

As described further below, the narrow portion 623 a may accommodatereceiving an end 632 of the tubing 630 therethrough, while the widerportion 623 b may accommodate slidably receiving a guide portion 662 ofthe camming element 660 therein. An o-ring 634 or other seal may beprovided within the throughbore 623, e.g., within the wider portion 623b immediately adjacent the male boss 627, to provide a fluid-tight sealbetween the tubing 630 and the inner housing 620, also as describedfurther below.

Similar to the previous embodiments, the inner housing 620 may bereceived within the outer shell 610, e.g., by inserting the male boss627 through the distal throughbore 618 into the proximal throughbore616, as shown in FIGS. 46B and 47B. When the male boss 627 is receivedin the proximal throughbore 616, the mating portion 628 may be receivedin the distal throughbore 618, e.g., contacting the abutment surface atthe intermediate location 619 when advanced fully into the outer shell610, and the male boss 627 may extend concentrically within and throughthe male Luer thread 614.

The mating portion 628 may have a diameter similar to the distalthroughbore 618, e.g., such that the mating portion 628 may slideaxially and rotate freely within the distal throughbore 618 withoutsubstantial lateral movement. In addition, one or more camming surfaces625 may be molded, machined, or otherwise provided along the matingportion 628. For example, the mating portion 628 may include one or morecamming surfaces 625 (three shown) spaced apart from one another aboutthe circumference of the mating portion 628 that extend helicallypartially around the mating portion 628, thereby defining a lowersurface of the inner housing 620. The camming surfaces 625 maycorrespond to similar camming surfaces 665 on the camming element 660,as described further below. Alternatively, other cooperating surfaces,ridges, grooves, and/or other features (not shown) may be provided onthe mating portion 628 and the camming element 660, i.e., to provideguiding features between the mating portion 628 and the camming element660. In addition or alternatively, any number of cooperating surfaces orother features, e.g., one or more, may be provided on the mating portion628 and camming element 660 to allow the mating portion 628 to moveaxially and/or helically relative to the camming element 660 duringactuation of the assembly 600, as described further below.

In addition, as best seen in FIGS. 45B and 49A-49D, the inner housing620 may include one or more indicator posts 624 spaced apart from oneanother about a circumference of the inner housing 620. For example, asshown, three posts 624 are provided on the mating portion 628 thatextend generally axially towards the proximal end 615 of the outer shell610 and the outer shell 610 may include corresponding openings 615 a inthe proximal end 615 aligned with the posts 624. For example, the posts624 may extend at least partially into or through the openings 615 awhen the assembly 600 is deactuated, i.e., when the assembly 600 isclosed to prevent fluid flow therethrough, as described further below.Optionally, the outer shell 610 may include one or more tracks on itsinner surface (not shown), if desired, for slidably receiving the posts624, e.g., to facilitate or limit movement of the inner housing 620relative to the outer shell 610.

The male boss 627 may include a seal 629 aligned with the throughbore623, e.g., at the proximal end 627 a of the male boss 627 forselectively sealing the assembly 600, as described further below. Forexample, as best seen in FIGS. 50A and 50B, the seal 629 may include acentral sealing pin 629 a supported by one or more supports 629 bextending radially inwardly from the proximal end 627 a of the male boss627. As shown, two supports 629 b may be disposed radially around thesealing pin 629 a, thereby defining a pair of openings through whichfluid may flow, although alternatively only one or three or moresupports (not shown) may be provided. The sealing pin 629 a may have aconical shape, as shown, or, alternatively, a frusto-conical or othershape (not shown) for sealing the end 632 of the tubing 630 secured inthe assembly 600.

With particular reference to FIGS. 45B, 46B, and 47B, the cammingelement 660 may be slidably disposed within the outer shell 610 betweenthe inner housing 620 and the backing member 640. The camming element660 may include a narrow guide portion 662 that is slidably receivedwithin the inner housing 620, e.g., within wider portion 623 b of thethroughbore 623, and a wider camming portion 664 that includes thecamming surfaces 665. The guide portion 662 includes an axial passage661 therethrough, e.g., having sufficient size to receive the tubing 630therethrough. For example, the passage 661 may be slightly larger thanthe tubing 630 such that the tubing 630 may be pushed through thepassage 661, yet provide a sufficient interference fit such thatsubsequent movement of the tubing 630 relative to the inner housing 620is coupled to the camming element 660, as described further below.Alternatively, the camming element 660 may include a seal or otherfeature (not shown) within the passage 661 to allow the tubing 630 to beinserted through the passage 661 but provide increased friction or otherinterference fit to couple movement of the tubing 630 and cammingelement 660. Optionally, the camming element 660 may include a recess663 to accommodate receiving one end of the spring member 650, asdescribed further below.

The camming surfaces 665 may be spaced apart from one another around thecircumference of the camming element 660, e.g., extending helicallypartially around an outer edge of the camming portion 664. The cammingsurfaces 665 may be configured to slidably contact and/or otherwiseinteract with the camming surfaces 625 on the inner housing 520, e.g.,to effect actuation and/or deactuation of the assembly 600, as describedelsewhere herein. Similar to the previous embodiments, the angle of thecamming surfaces 625, 665 may be changed, e.g., to correspond to theselected configuration, e.g., number and/or orientation of the cammingsurfaces 625, 665, for example, to maximize fluid flow upon actuation.

In addition, the camming element 660 includes a plurality of indicatorposts 668, 669 spaced apart about a circumference of the camming element660, e.g., extending from the outer surface of the camming portion 664.For example, as shown, the camming element 660 includes three relativelyshort posts 668 and three relatively long posts 669 alternately spacedapart about the camming portion 664. The indicator posts 668 may extendaxially from the camming portion 624, e.g., towards the backing member640 to provide indicators when the assembly 600 has been actuated, i.e.,open to allow fluid flow therethrough, as described further below. Theindicator posts 669 also extend axially but have sufficient length suchthat first ends 669 a of the posts 669 extend through correspondingopenings 615 a in the outer shell 610 when the assembly 600 isdeactuated and second ends 669 b of the posts 669 extend throughcorresponding openings 649 in the backing member 640 when the assembly600 is actuated. The posts 668, 669 may also prevent rotation of thecamming element 660 relative to the outer shell 610 and/or backingmember 640, also as described further below. For example, the outershell 610 and/or backing member 640 may include one or more tracks orother recesses for slidably receiving one or more of the indicator posts668, 669, e.g., to allow the camming element 660 to slide axiallywithout rotating within the outer shell 610. In addition oralternatively, the camming member 660 and the outer shell 610 or backingmember 640 may include one or more features, e.g., tracks, tabs or otherguide elements, and the like (not shown) to allow the camming member 660to move axially without substantial rotational movement relative to theouter shell 610, e.g., similar to the previous embodiments.

As best seen in FIGS. 45A-47C, the backing member 640 includes a baseportion 646 including a passage 642 therethrough, and an annular portion644 extending proximally from the base portion 646. The passage 642 mayhave sufficient size to accommodate receiving the tubing 630therethrough, optionally including a tapered or otherwise shaped lowersurface to facilitate inserting the end 632 of the tubing 630 into thepassage 642 during assembly, as described further below. The annularportion 644 may define a recess 645 for receiving one end of the elasticmember 650 (or other elastic member) therein, e.g., such that oppositeends of the elastic member 650 may be received in the recesses 645, 663,thereby capturing the elastic member 650 between the backing member 640and the camming element 660. As best seen in FIG. 45C, the annularportion 644 may be divided into separate curved portions, e.g., toaccommodate receiving respective ridges 617 therebetween, e.g., toconnect the backing member 640 to the outer housing 610.

The backing member 640 may include one or more openings 649, e.g.,extending axially along the annular portion 644 for slidably receivingcorresponding posts 668, 669 on the camming member 660, e.g., when theassembly 600 is actuated to the open condition. Optionally, the openings649 may extend proximally a sufficient distance to provide guide tracksfor the posts 668, 669, e.g., to allow axial movement of the cammingelement 660 without substantial rotation.

The backing member 640 may also include one or more connectors forattaching the backing member 640 to the outer shell 610. For example,grooves 648 may be provided around the base portion 646 between thecurved portions of the annular portion 644 for receiving respectiveridges 617 on the outer shell 610. Alternatively, the backing member 640may include one or more other connectors (not shown) that may cooperatewith corresponding connectors (also not shown) on the outer shell 610,e.g., for coupling the backing member 540 to the outer shell 510.

The elastic member 650 may be a compression spring having a diametersmaller than the recesses 645, 663. For example, the inner diameter ofthe spring 650 may be sized to be received around the tubing 630, e.g.,such that the elastic member 650 does not interference with insertion ofthe end 632 of the tubing 630 into the backing member 640, cammingelement 660, and into the inner housing 620. Opposite ends of theelastic member 650 may press against the backing member 640 and cammingelement 660 such that the elastic member 650 may bias the cammingelement 660 and inner housing 620 away from the backing member 640and/or towards the proximal end 615 of the outer shell 610, as describedfurther below.

During manufacturing, the components of the assembly 600 may be formedand assembled together. Although exemplary methods are described herein,it will be appreciated that the order of the various stages or stepsand/or the particular steps used may be changed, as desired, e.g., basedupon manufacturing convenience and/or other factors. For example, eachof the outer shell 610, inner housing 620, backing member 650, andcamming element 660 may be integrally molded, machined, or otherwiseformed separately from one another, e.g., from plastic, metal, orcomposite material, similar to the previous embodiments.

The inner housing 620 may be inserted into the distal end 613 of theouter shell 610, as described above, and the camming element 660 may beinserted into the distal end 613 of the outer shell 610, e.g., after orsimultaneously with the inner housing 620. During insertion, the guideportion 662 of the camming element 660 may be inserted into the widerportion 623 b of throughbore 623 of the inner housing 620, e.g., untilthe camming surfaces 665 contact camming surfaces 625 on the innerhousing 620. The elastic member 650 may be inserted into the distal end613 of the outer shell 610, e.g., until one end is received within therecess 663 of the camming element 660.

The backing member 640 may then be inserted into the distal end 613 ofthe outer shell 610, for example, by aligning the ridge portions 617 ofthe outer shell 610 between the curved portions of the annular portion644, e.g., such that the ridge portions 617 engage respective grooves648 between the curved portions 644 in the backing member 640. As thebacking member 640 is secured within the outer shell 610, the oppositeend of the elastic member 650 may be received within the recess 645within the backing member 640, e.g., slightly compressing the elasticmember 650 between the camming element 660 and the backing member 640.

The distal end 632 of a length of tubing or other conduit 630 may beinserted into the backing member 640 through the passage 642, throughthe passage 661 in the camming element 660, and through the narrowportion 623 a of the throughbore 623 of the inner housing 620. Thebacking member 640 may include a tapered surface or other features (notshown) communicating with the passage 642, e.g., to facilitate initiallyinserting the tubing 630 into the passage 642. The tubing 630 may passfreely through the interior of the elastic member 650 and then throughthe passage 661 in the camming element 660 with sufficient force toovercome friction between the tubing 630 and the wall of the passage661, e.g., until the tubing 630 contacts the o-ring 634. The tubing 630may then be directed through the o-ring 634 and into the narrow portion623 a of the throughbore 623 until the distal end 632 of the tubing 630abuts the sealing pin 629 a.

The distal end 632 of the tubing 630 may substantially engage thesealing pin 629 a, thereby providing a fluid-tight seal that preventssubstantial fluid flow through the distal end 632 of the tubing 630.Thus, the tubing 630 may be secured axially relative to the cammingelement 660, e.g., such that friction provides an interference fitbetween the tubing 630 and the wall of the passage 661 in the cammingelement 660, while the tubing 630 may be free to move axially relativeto the inner housing 620, outer shell 610, and/or backing member 640. Inaddition or alternatively, an adhesive or other fastening method may beused to fix the tubing 630 relative to the camming element 660, ifdesired.

The tubing 630 may be formed from flexible material, e.g., silicone andthe like, which may facilitate sealing between the distal end 632 andthe sealing pin 629 a. In addition or alternatively, the tubing 630 maybe formed from material that accommodates receiving particulartherapeutic and/or diagnostic compounds or other fluids therethrough,e.g., that may be inert to corrosive or other compounds to be deliveredthrough the assembly 600. The tubing 630 may have sufficient length suchthat a free end (not shown) of the tubing 630 may be connected to afluid line, e.g., for an IV or other device (not shown). The free end ofthe tubing 630 may include a connector (not shown), such as a male orfemale Luer fitting, and the like, to facilitate connection to a fluidline. Alternatively, the tubing 630 may communicate with another device,such as those described elsewhere herein.

It will be appreciated that the tubing 630 may be inserted into theother components of the assembly 600 immediately before use, or duringinitial manufacturing, as desired. Alternatively, the tubing 630 may bereceived within the passage 661 and attached to the camming element 660before inserting the camming element 660 into the outer shell 610 andinner housing 620, if desired. Optionally, as shown in FIG. 51, thebacking member 640′ may include a cavity or passage 645′ for receivingexcess length of the tubing 630 inserted through the backing member 640.Such a configuration may facilitate movement of the tubing 630 axiallywithin the outer shell 610 without the tubing 630 moving into or out ofthe backing member 640.

During use, the assembly 600 may be initially provided as shown in FIGS.45A, 45B, 48A, and 50A. In this condition, the assembly 600 may be in aclosed position, e.g., with the end 632 of the tubing 630 substantiallysealed by the seal 629 on the inner housing 620, e.g., as best seen inFIG. 50A. In the closed position, the elastic member 650 may press thecamming element towards the proximal end 615 of the outer shell 610,thereby pushing the inner housing 620 proximally, e.g., until the maleboss 627 is received within the male Luer thread 614 and the matingportion 628 abuts the abutment surface at the intermediate location 619in the outer shell 610, e.g., as best seen in FIG. 45B. One advantage ofthis configuration is that the end 632 of the tubing 630 and the seal629 are exposed, which may facilitate cleaning the end 632 and seal 629during use.

As shown in FIGS. 45A and 48A, in the closed position the posts 624 andends 669 a of posts 669 may be received in the openings 615 a in theouter shell 610, e.g., providing a visual confirmation that the assembly600 is in the closed position. Optionally, the posts 624 and ends 669 amay include one or more visual markers, e.g., a color, such as red,text, and the like (not shown), which may enhance identification of thestatus of the assembly 600, similar to the previous embodiments.

Turning to FIGS. 48B-48D and 49A-49D, a female Luer fitting 160 may bethreaded into the outer shell 610, e.g., by threading the fitting 160into the male Luer thread 614, similar to the previous embodiments,which may secure the female Luer fitting 160 to the assembly 600 andactuate the assembly 600. Alternatively, the assembly 600 may beconfigured to include a female Luer fitting (not shown), similar toother embodiments described herein, and a male Luer fitting (also notshown) may be coupled to the assembly 600 during use.

When the fitting 160 is initially threaded into the outer shell 610, thefitting 160 may contact the male boss 627 on the inner housing 620. Oncethe fitting 160 is fully engaged with the male boss 627, furtherthreading of the fitting 160 causes the inner housing 620 and cammingelement 660 to move distally relative to the outer shell 610 and thebacking member 640, as shown in FIGS. 48B and 49A. Because the posts 624of the inner housing 620 are received in openings 615 a, the innerhousing 620 initially is limited to axial distal movement withoutsubstantial rotation relative to the outer shell 610. Optionally, theopenings 615 a in the outer shell 610 may communicate with slots orother tracks extending along the inner surface of the outer shell 610 toslidably receive the posts 624 and prevent rotation of the inner housing620 while the posts 624 are within the slots.

Similarly, because the posts 668, 669 on the camming element 660 arereceived in slots communicating with the openings 649 in the backingmember 640 (and/or with slots or other tracks extending along the innersurface of the outer shell 610), the camming element 660 is limited toaxial movement and limited from rotating substantially relative to theouter shell 610. As the fitting 160 is inserted, pushing the innerhousing 620 and camming element 660 distally, the elastic member 650 maybe compressed between the camming element 660 and backing member,thereby storing potential energy in the elastic member 650. As the innerhousing 620 and camming element 660 move distally, the end 632 of thetubing 630 may remain substantially engaged with the seal 629, thusmaintaining the assembly 600 in the closed position and preventing fluidfrom leaking from the end 632 of the tubing 630.

Turning to FIGS. 48C and 49C, once the posts 624 pass below the openings615 a and any slots or tracks within the outer shell 610, furtherthreading of the fitting 160 continues to cause distal movement of theinner housing 620 but also causes the inner housing 620 to rotate, i.e.,move helically distally relative to the backing member 540. Because ofthe cooperating camming surfaces 625, 665 on the inner housing 620 andcamming element 660, the camming element 660 remains in its proximalposition (shown in FIGS. 49B and 49C) until the inner housing 620rotates completely, whereupon the camming surface 625, 665 push thecamming element 660 distally relative to the inner housing 620, outershell 610, and backing member 640, as shown in FIGS. 48D and 49D.

As the camming element 660 moves distally, the posts 668, 669 are alsodirected distally until the posts 668 and ends 669 b of posts 669 arereceived in the openings 649 in the backing member 640. Because thetubing 630 is coupled to the camming element 660, as the camming element660 moves distally relative to inner housing 620, the end 632 of thetubing 630 moves distally relative to seal 629, thereby opening thedistal end 632 and allowing fluid flow through the tubing 630 and intothe fitting 160, similar to the previous embodiments. Because of thecooperation of the camming surfaces 625, 655, and the movement of theposts 624, 668, 669 relative to the outer shell 610, this actuation ofthe assembly 600 does not occur until the fitting 160 is substantiallyfully threaded into the male Luer thread 614. Thus, the end 632 of thetubing 630 is not opened until the fitting 160 is substantially fullythreaded into the male Luer 614 of the outer shell 610, therebysubstantially reducing the risk of fluid leaking from the tubing 630prematurely. This may be particularly important for certain corrosive,toxic, or other compounds are being delivered through the assembly 600.When the posts 668, 669 b appear in the openings 649, they provide avisual indication that the assembly 600 has been opened and that fluidmay then flow through the assembly 600, as shown in FIGS. 48D and 49D.Optionally, the posts 668, 669 b may include markers, similar to thosedescribed above, for facilitate visually identifying that the assembly600 is in its open condition.

Optionally, the assembly 600 may include one or more features forreleasably locking the assembly 600 in the open condition. For example,as best seen in FIGS. 49A-49D, the inner surface of the outer shell 600may include one or more pockets 611 a that may receive respective posts624 on the inner housing 620. As the inner housing 620 is displacedaxially and then rotationally within the outer shell 610 duringactuation, the posts 624 may enter the pockets 611 a such that the posts624, and consequently, the inner housing 620 cannot move proximallyand/or rotate. Thus, if the fitting 160 is fully threaded and released,the inner housing 620 may be prevented from moving axially, which mayotherwise cause the fitting 160 to unthread from the assembly 600.Alternatively, other features (not shown) may be provided, e.g., on theinner housing 620 and/or outer shell 610 to lock the assembly 600 in theopen condition.

When it is desired to discontinue flow through the assembly 600, thefitting 160 may simply be unthreaded from the male Luer thread 614. Assoon as the posts 624 of the inner housing 620 are withdrawn from thepockets 611 a, the bias of the elastic member 650 may push the cammingelement 660 proximally as the fitting 160 is unthreaded. The cammingsurfaces 625, 665 may then cooperate to immediately direct the cammingelement 660 proximally relative to the inner housing 620, therebyreengaging the end 632 of the tubing 630 with the seal 629. Thus, assoon as a user begins to unthread the fitting 160, the end 632 of thetubing 630 may be immediately sealed, thereby closing the assembly 600from further fluid flow. As the fitting 150 is unthreaded, the innerhousing 620 may return to its initial rotational orientation and thenmove proximally along with the camming element 660 until the posts 624,669 a reappear in the openings 615 a in the outer shell 610. Thus, theuser knows that fluid flow has discontinued and the assembly 600 hasbeen returned to the closed position. If desired, the assembly 600 maybe cleaned and/or reconnected to a new fitting 160, as desired.

Any of the assemblies described herein may be provided directly on endsof a fluid line, e.g., an IV or other medical line, as describedelsewhere herein. Alternatively, the assemblies may be provided asindependent components or may be incorporated into other products ordevices, e.g., to provide systems for delivering fluids, e.g., within amedical setting.

For example, turning to FIGS. 33A-34B, an exemplary embodiment of a tubeholder 1100 is shown that includes an integral valve 1101 similar to theassembly 200 shown in FIGS. 7A-12D. Generally, the tube holder 1100includes a housing 1102 including an open end 1104 and a closed end1106, thereby defining a cavity 1108 for receiving a vacuum-sealed testtube or other container (not shown). A needle 1110 is provided in thecavity 1108, e.g., fixed to the closed end 1106 for penetrating a plenumor other penetrable seal on a test tube or container (also not shown).The closed end 1106 may include a hub 1140 including features similar tothe backing member 240 shown in FIG. 10A, except that the closed end1106 replaces the base portion 246. For example, the hub 1140 mayinclude an annular member including slots (not shown) molded with orotherwise extending from the closed end 1106 of the tube holder 1100.

In addition, the valve 1101 includes an outer shell or bezel 210including a covering body or inner housing 220, a shaft, cammingelement, and elastic member (not shown) therein, e.g., which may beconnected to the hub 1140, similar to the assembly 200. It will beappreciated that any of the embodiments described herein may be providedfor the valve 1101, e.g., including a male or female Luer connection. Asshown in FIGS. 33A and 33B, the valve 1101 is in a closed or deactuatedcondition, i.e., with a fluid path therethrough closed. In contrast, asshown in FIGS. 34A and 34B, a female Luer fitting 160 has been threadedinto the bezel 210, thereby actuating the valve 1101. In the actuatedcondition, a fluid path is opened that communicates from the needle 1110through the valve 1101 to the female Luer fitting 160, similar toembodiments described elsewhere herein. In the actuated condition, oneor more status indicators 1146 may become visible on the hub 1144.

During use, a test tube, vial, or other container (not shown) may beinserted into the open end 1104 of the tube holder 1100, e.g., until theneedle 1110 penetrates the seal of the container, thereby communicatingwith an interior of the container. In this condition, the valve 1101remains closed, thereby preventing fluid flow into and/or out of thecontainer. The user may then thread the female Luer fitting 160 into thevalve 1101, thereby opening the fluid path and allowing fluid to flowthrough the valve 1101. The user may affirmatively identify that thefluid path is opened when the status indicator(s) 1146 become visible.

For example, the female Luer fitting 160 may be coupled to a fluid line,e.g., a Butterfly needle or other tube communicating with a vein of apatient. When the female Luer fitting 160 is threaded into the valve1101, the fluid path is opened, which exposes the female Luer fitting160 (and fluid line) to the vacuum within the container received in thetube holder 1100, thereby pulling blood from the patient's vein throughthe fluid line and valve 1101, and into the container. When sufficientblood is received within the container, the user may simply unthread thefemale Luer fitting 160, thereby closing flow through the valve 1101into the container. If desired, the container may be replaced withanother container, and the female Luer fitting 160 connected to fillanother container, and the process may be repeated as desired. The valve1101 may minimize leakage that may otherwise occur when containers areexchanged on a tube holder without the valve 1101.

Turning to FIGS. 35A-36B, another exemplary embodiment of a tube holder1100′ is shown that includes an integral valve 1101′ similar to theassembly 300 shown in FIGS. 13A-16B. Similar to the previous embodiment,the tube holder 1100′ includes a housing 1102′ including an open end1104,′ a closed end 1106,′ a cavity 1108′ for receiving a container (notshown), and a needle 1110,′ e.g., fixed to the closed end 1106′ forpenetrating a seal on the container (also not shown). The closed end1106′ may include a hub 1140′ including features similar to the backingmember 340 shown in FIGS. 14A, 14B.

In addition, the valve 1101′ includes an outer shell or bezel 310including a covering body, shaft, camming element, and elastic member(not shown) therein, e.g., which may be connected to the hub 1140,′similar to the assembly 300. It will be appreciated that any of theembodiments described herein may be provided for the valve 1101, e.g.,including a male or female Luer connection. As shown in FIGS. 35A and35B, the valve 1101′ is in a closed or deactuated condition, i.e., witha fluid path therethrough closed, while in FIGS. 36A and 36B, a maleLuer fitting 160′ has been threaded onto the proximal end 315 of thebezel 310, thereby actuating the valve 1101.′ In the actuated condition,a fluid path is opened that communicates from the needle 1110 throughthe valve 1101 to the female Luer fitting 160, similar to embodimentsdescribed elsewhere herein.

Operation of the tube holder 1100′ and valve 1101′ are similar to theprevious embodiment. For example, a container (not shown) may beinserted into the open end 1104′ of the tube holder 1100,′ e.g., untilthe needle 1110′ penetrates the seal of the container. In thiscondition, the valve 1101′ remains closed, thereby preventing fluid flowinto and/or out of the container. The user may then thread the male Luerfitting 160′ onto the valve 1101,′ thereby opening the fluid path andallowing fluid to flow through the valve 1101.′ The user mayaffirmatively identify that the fluid path is opened when the statusindicator(s) 1146′ become visible.

Turning to FIGS. 37A-38B, another embodiment of a device including anintegral valve 1201 is shown. In this embodiment, the device is asyringe 1200 that includes a barrel 1202 including an open proximal end1204, a substantially closed distal end 1206, and defining a chamber1208 therein. A plunger 1210 is slidably disposed in the chamber 1208,e.g., that may be withdrawn to draw fluid into the chamber 1208 throughthe distal end 1206 and/or that may be depressed to eject fluid in thechamber 1208 out through the distal end 1206. The distal end 1206includes a hub 1240 similar to the hub 1140 of the tube holder 1100described above, e.g., including features similar to the backing member240 shown in FIG. 10A, except that the closed end 1206 replaces the baseportion 246. For example, the hub 1240 may include an annular memberincluding slots (not shown) molded with or otherwise extending from theclosed end 1206 of the syringe 1200.

The valve 1201 includes an outer shell or bezel 210 including a coveringbody or inner housing 220, a shaft, camming element, and elastic member(not shown) therein, e.g., which may be connected to the hub 1240,similar to the assembly 200. It will be appreciated that any of theembodiments described herein may be provided for the valve 1201, e.g.,including a male or female Luer connection. As shown in FIGS. 37A and37B, the valve 1201 is in a closed or deactuated condition, i.e., with afluid path therethrough closed. In contrast, as shown in FIGS. 38A and38B, a female Luer fitting 160 has been threaded into the bezel 210,thereby actuating the valve 1201. In the actuated condition, a fluidpath is opened that communicates from the chamber 1208 of the syringe1200 through the valve 1201 to the female Luer fitting 160, similar toembodiments described elsewhere herein. In the actuated condition, oneor more status indicators 1246 may become visible on the hub 1244.

During use, the syringe 1200 may be provided preloaded with a desiredtherapeutic and/or diagnostic fluid within the chamber 1208 of thebarrel 1202, e.g., with the plunger 1210 in a proximal position. In thiscondition, the valve 1201 remains closed, thereby preventing the fluidfrom flowing out of the syringe 1200. Thus, unlike conventionalsyringes, the valve 1210 may prevent inadvertent advancement of theplunger 1210, which would otherwise allow fluid to be ejected orotherwise escape from the chamber 1208.

When it is desired to deliver the fluid, the user may then thread thefemale Luer fitting 160 into the valve 1201, thereby opening the fluidpath through the valve 1201. The user may then depress the plunger 1210distally, thereby ejecting the fluid from the chamber 1208 through thevalve 1201 and female Luer fitting 160. For example, the female Luerfitting 160 may be connected to an IV or other fluid line communicatingwith a vein of a patient, thereby delivering the fluid to the patient.When it is desired to prevent further fluid flow, the user may ceasedepressing the plunger and/or may unthread the female Luer fitting 160.When the female Luer fitting 160 is unthreaded, the valve 1201 isdeactuated, thereby again preventing fluid flow from the syringe 1200.

In an alternative embodiment, the syringe 1200 may be provided initiallyempty, and the valve 1201 may be opened upon connecting a source offluid to the valve 1201. The plunger 1210 may then be withdrawn to drawfluid into the chamber 1208, e.g., immediately before delivery to apatient. Once sufficient fluid is loaded into the syringe 1200, thefluid may be delivered as described above. The valve 1201 may allowfluids to be loaded into and/or delivered from the syringe 1200 withenhanced safety over conventional syringes.

Turning to FIGS. 39A-40B, another embodiment of a syringe 1200′ is shownthat includes an integral valve 1201.′ Similar to the previousembodiment, the syringe 1200′ includes a barrel 1202′ including an openproximal end 1204,′ a substantially closed distal end 1206,′ a chamber1208,′ and a plunger 1210 slidable in the chamber 1208.′ The distal end1206′ includes a hub 1240′ similar to the hub 1140′ of the tube holder1100′ described above, e.g., including features similar to the backingmember 340 shown in FIGS. 14A, 14B.

In addition, the valve 1201′ includes an outer shell or bezel 310including a covering body, shaft, camming element, and elastic member(not shown) therein, e.g., which may be connected to the hub 1240,′similar to the assembly 300.

As shown in FIGS. 39A and 39B, the valve 1201′ is in a closed ordeactuated condition, i.e., with a fluid path therethrough closed, whilein FIGS. 40A and 40B, a female Luer fitting 160′ has been threaded intothe bezel 310, thereby actuating the valve 1201.′ Otherwise, the syringe1200′ and valve 1201′ may be used similar to the previous embodiment.

Turning to FIGS. 41A-41C, an exemplary embodiment of a valve assembly1300 is shown that includes components similar to the assembly 200 shownin FIGS. 7A-12D. Generally, the assembly 1300 includes an outer shell orbezel 1310 and backing member 1340, together providing an outer packageor housing for the assembly 1300, a covering body or inner housing 1320,a shaft, core pin, or tubular member 1330 (only partially shown in FIG.41A), a camming member (not shown), and an elastic member (also notshown).

For example, similar to FIG. 8, the outer shell 1310 includes proximaland distal ends 1315, 1313, a distal throughbore (not shown), and aproximal throughbore 1316 including a male Luer thread 1314 therein, asbest seen in FIG. 41A. Similar to FIGS. 7B and 7C, the covering body1320 includes an elongated male boss 1327 with a deformable membrane1329 attached thereto, as best seen in FIG. 41A. Similar to the previousembodiments, the covering body 1320 may be received within the outershell 1310, e.g., by inserting the male boss 1327 through the distalthroughbore into the proximal throughbore 1316. Similar to FIGS. 9A and9B, the shaft 1330 generally includes a throughbore extending betweenfirst and second ends of the conduit (not shown), a mating member with aplurality of cam features (not shown), and a fluid cap 1336, onlypartially seen in FIG. 41A. Finally, similar to FIG. 10A, the backingmember 1340 includes a base portion 1346, and an annular portion 1344extending into the bezel 1310 from the base portion 1346, togetherdefining a throughbore 1345.

Unlike the previous embodiments, the backing member 1340 includes a hub1349 including a female Luer connector 1349 a extending from the baseportion 1346 opposite the annular portion 1344. Alternatively, otherconnectors (not shown) may be provided on the hub 1349 instead of theLuer connector 1349 a, as desired.

Before use, the components of the assembly 1300 may be assembledtogether, e.g., during manufacturing, similar to previous embodimentsdescribed herein. For example, a proximal end of the shaft 1330 may beinserted into the covering body 1320 until the fluid cap 1336 isreceived within the opening of the deformable membrane 1329. Thecovering body 1320 (with the shaft 1330 therein) may be inserted intothe outer shell 1310, e.g., into the distal throughbore until the maleboss 1327 enters the proximal throughbore 1316. The camming element (notshown) may be inserted over and around the shaft 1330 and into thedistal throughbore of the outer shell 1310, e.g., until the cammingelement is captured or received within the outer shell 1310. The backingmember 1340 may be inserted into the distal end 1313 of the outer shell1310, e.g., around the shaft 1330 and camming element. This may involvealigning features (not shown) in the annular portion 1344 of the backingmember 1340 with corresponding features (also not shown) on the cammingelement and/or covering body 1320 to secure the backing member 1340 andallow camming of the shaft 1330 during actuation, similar to theassembly 200.

Once assembled, the shaft 1330 may be slidably received within thethroughbore of the backing member 1340. For example, the throughbore ofthe backing member 1340 may be sized to receive a distal end (not shown)of the shaft 1330, e.g., such that the shaft 1330 may rotate relative tothe backing member 1340 and may movable axially within the throughbore.The shaft 1330 may extend into the throughbore without extendingcompletely through the backing member 1340, e.g., without extending intothe hub 1349. The throughbore of the backing member 1340 and the distalend of the shaft 1330 may be sized to provide a substantiallyfluid-tight seal therebetween during use of the assembly 1300.

Unlike the assembly 200, the assembly 1300 may be provided as anindependent component, which may be connected into a fluid line, asdesired. For example, a syringe, tubing, container, and the like may beprovided that already include a male Luer fitting (not shown). Theconnector 1349 a may be threaded into the connector, thereby couplingthe assembly 1300 to the fluid line, but with the assembly 1300remaining in the deactuated position, as shown in FIGS. 41A-41C. Whendesired, e.g., to deliver fluid via the fluid line, another end of thefluid line (also not shown) may be connected to the male Luer connector1314 on the outer shell 1310, similar to previous embodiments. Thisaction may cause the outer shell 1310 to move proximally, therebyrotating the shaft 1330 within the covering body 1320 and opening thefluid path through the assembly 1300.

Optionally, when a female Luer connector (not shown) is tightened intothe proximal end 1315 of the outer shell 1310, a region of the annularportion 1344 of the backing member 1340 may become exposed. If desired,an actuated status indicator (not shown) may be provided on the annularportion 1344, similar to that shown in FIG. 12A, which may becomeexposed only when the female Luer connector is finally tightened to theouter shell 1310. When it desired to discontinue fluid flow, the femaleLuer connector may be unthreaded from the outer shell 1310, similar tothe previous embodiments.

Turning to FIGS. 42A-42C, another embodiment of a valve assembly 1400 isshown that includes components similar to the assembly 300 shown inFIGS. 13A-16B. Generally, the assembly 1400 includes an outer shell orbezel 1410 and backing member 1440, together providing an outer packageor housing for the assembly 1400, a covering body or inner housing 1420,a shaft, core pin, or tubular member 1430 (only partially shown in FIG.42A), a camming member (not shown), and an elastic member (also notshown).

Unlike the assembly 300, the backing member 1440 includes a hub 1449including a male Luer connector 1449 a extending from the base portion1446 opposite the annular portion 1444. Alternatively, other connectors(not shown) may be provided on the hub 1449 instead of the Luerconnector 1449 a, as desired. Otherwise, assembly and use of theassembly 1400 is similar to other embodiments described elsewhereherein.

Turning to FIGS. 43A-43C, an exemplary embodiment of a dual valveassembly 1500 is shown. Generally, the assembly 1550 includes a pair ofvalves that share a common backing member 1540 and fluid path. In theembodiment shown, a first valve 1500A is provided, which may be similarto the assembly 200 shown in FIGS. 7A-12D, and a second valve 1500B isprovided, which may be similar to the assembly 300 shown in FIGS.13A-16B. Generally, each valve 1500A, 1500B includes an outer shell orbezel 1510A, 1510B, a covering body or inner housing 1520A, 1520B, ashaft, a camming member, and an elastic member (not shown) within therespective bezel 1510A, 1510B. The components of each valve 1500A, 1500Bmay be assembled together on respective sides of the backing member1540, which includes appropriate features for connecting the componentsand allowing each valve 1500A, 1500B to be operated independently of theother.

The fluid path through the assembly 1500 may remain substantially closeduntil both valves 1500A, 1500B are actuated, i.e., secured to respectiveends of a fluid line (not shown). For example, a female Luer fitting(not shown) may be threaded into the male Luer connector 1515A of thefirst valve 1500A, which may actuate the first valve 1500A. However,because the second valve 1500B is still closed, the fluid path throughthe assembly 1500 remains closed. When a male Luer fitting (not shown)is then threaded over the female Luer connector 1515B, the second valve1500B may be actuated, thereby opening the fluid path and allowing fluidto flow through the fluid line via the assembly 1500. For example, thefemale Luer fitting may be connected to tubing communicating with asource of fluid (not shown), while the male Luer fitting may beconnected to tubing communicating with a patient, e.g., to an infusionset previously placed in the patient's vein. With both valves 1500A,1500B actuated, fluid may flow from the source through the assembly 1500and into the patient.

One potential advantage of the assembly 1500 is that it may create adesired pressure within the fluid line when the valves 1500A, 1500B areactuated and/or deactuated. For example, it may be desirable to create apositive or negative pressure within the fluid path through the assembly1500 during connection or disconnection from the fluid line. As anexample, in some applications, it may be desirable to create a slightnegative pressure within the assembly 1500 during disconnection, e.g.,to draw any residual fluid into the assembly 1500 and reduce the risk ofexposure of the residual fluid to the surrounding environment, e.g., tothe user, patient, and the like. Alternatively, in some applications, itmay be desirable to create a slight positive pressure duringdisconnection to eject any residual fluid from within the fluid path ofthe assembly 1500, e.g., to reduce coagulation of blood or other fluidwithin the assembly 1500 between fluid delivery. In another alternative,the valves 1500A, 1500B may be configured to create a net substantiallyzero pressure change during connection and/or disconnection.

In the exemplary assembly 1500 of FIGS. 43A-43C, either of actuation anddeactuation of the valves 1500A, 1500B creates a substantially net zeropressure change within the fluid path. It will be appreciated that otherembodiments of valves, such as the assemblies described elsewhere hereinmay be provided for either of the valves 1500A, 1500B.

Turning to FIGS. 44A-44C, another embodiment of a dual valve assembly1600 is shown that may generally operate similar to the dual valveassembly 1500 shown in FIGS. 43A-43C. The assembly 1600 includes a firstvalve 1600A, which may be similar to the assembly 200 shown in FIGS.7A-12D, and a second valve 1600B is provided, which may be similar tothe assembly 300 shown in FIGS. 13A-16B. Generally, each valve 1600A,1600B includes an outer shell or bezel 1610A, 1610B, a backing member1640A, 1640B, a covering body or inner housing 1620A, 1620B, a shaft, acamming member, and an elastic member (not shown). The components ofeach valve 1600A, 1600B may be assembled together independently of theother, unlike the preceding embodiment. Instead, respective ends of alength of tubing 1670 may be connected to the valves 1600A, 1600B. e.g.,to the respective shafts and/or backing members, similar to the previousembodiments.

Each valve 1600A, 1600B may be connected to a fluid line, e.g., to afemale Luer fitting and male Luer fitting, respectively. With one orboth valves 1600A, 1600B deactuated, the fluid path through the assembly1600 may remain substantially closed. Thus, fluid may only flow whenboth valves 1600A, 1600B are actuated, i.e., engaged to respective endsof a fluid line and opened. Similar to the previous embodiment, theconfiguration of the valves 1600A, 1600B may be selected to provide anet pressure differential within the fluid path during actuation and/ordeactuation, as desired.

The foregoing disclosure of the exemplary embodiments has been presentedfor purposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise forms disclosed.Many variations and modifications of the embodiments described hereinwill be apparent to one of ordinary skill in the art in light of theabove disclosure. For example, elimination of some components, such asthe flexible sleeve that deforms in actuation, is possible and withinthe scope of the present invention. Another method may include allowingthe core to rotate and deform the tip of the male Luer without the needfor a sleeve. The scope of the invention is to be defined only by theclaims appended hereto, and by their equivalents.

Further, in describing representative embodiments, the specification mayhave presented the method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described. Asone of ordinary skill in the art would appreciate, other sequences ofsteps may be possible. Therefore, the particular order of the steps setforth in the specification should not be construed as limitations on theclaims.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

I claim:
 1. A needleless device actuated by rotation, the devicecomprising: a covering body; a deformable sleeve fixed to the inside ofa first end of the covering body, and having a geometrically-shapedhollow center; and a fluid cap having a geometrical shape substantiallysimilar to the hollow center of the deformable sleeve, and having atleast one opening on the sides of the fluid cap contacting thedeformable membrane; wherein initially the openings are occluded by thedeformable sleeve; and whereby a non-passive rotation of the fluid capinside the deformable sleeve creates a plurality of gaps between thefluid cap and the hollow center to allow fluid flow.
 2. The device inclaim 1, wherein the covering body has a boss of the Luer type.
 3. Thedevice in claim 2, wherein the covering body is surrounded by an outershell with thread.
 4. The device in claim 3, wherein the thread is onthe inside of the outer shell and the boss projects beyond the outershell.
 5. The device of claim 3, wherein the thread is on the outside ofthe outer shell and the boss resides inside the outer shell.
 6. Thedevice in claim 3, wherein the device is attached to a syringe.
 7. Thedevice in claim 3, wherein the device is attached to an IV catheter. 8.The device in claim 1, further comprising a complementary actuatingdevice at an end opposite the first actuating device.
 9. The device inclaim 1, wherein the geometric shape of the hollow center and the fluidcap is a polygon.
 10. The device of claim 3, wherein a plurality ofstatus indicators are observable when viewing the outer shell, thestatus indicators signifying when fluid flow is allowed and not allowed.11. A needless medical connector device, the device comprising an outershell having a Luer type thread; a plurality of status indicatorsobservable when viewing the outer shell; a boss inside a first end ofthe shell; a deformable sleeve inside a first end of the boss, andhaving a geometrically-shaped hollow center; a conduit inside the bossand extending through the length of the outer shell; and a fluid cap,which has a geometric shape substantially similar to the hollow centerof the deformable sleeve in which it resides, having at least oneopening occluded by the deformable membrane; whereby engaging theconnector non-passively causes the conduit to rotate within the boss,which results in a mismatch between the once aligned geometric shapes ofthe deformable sleeve and fluid cap, creating a plurality of gaps toform a fluid path between the deformable sleeve and the fluid cap; andwherein the status indicators signify when the fluid path is actuated ordeactuated.
 12. The device in claim 11, wherein the deformable membraneis made from a material that permits elastic deformation.
 13. The devicein claim 11, wherein the thread is on the inside of the outer shell andthe boss projects beyond the outer shell.
 14. The device in claim 11,wherein the thread is on the outside of the outer shell and the bossresides inside the outer shell.
 15. The device in claim 11, wherein thegeometric shape of the hollow center and fluid cap is a polygon.
 16. Thedevice in claim 11, wherein the status indicators are revealed throughwindows cut out of the outer shell in order to signify actuation ordeactuation.
 17. A connecting assembly, the assembly comprising: anouter shell having a polygon shape and status windows revealing when theassembly is in an actuated or deactuated state, a covering bodycomprised of pegs, an outer mating surface, and a deformable membraneattached to the inner surface of a first end of the covering body; arotating member used to effect actuation of the assembly; a shaftcomprised of pegs, a mating member with triangular indentations, and afluid cap having at least one opening to allow fluid flow afteractuation of the assembly; a backing member having triangularprojections used to mate with the mating member; wherein the fluid capinitially resides within and matches up with the deformable membrane inthe deactuated state; wherein the fluid cap, after being rotated, doesnot match up with the deformable membrane in this actuated state therebycreating gaps between the deformable membrane and the fluid cap to allowfluid flow; and wherein the triangular projection keep the assemblyactuated until the assembly is deactuated by the shaft to rotating backto its original position via the rotating member.
 18. The assembly inclaim 17, wherein the rotating member is selected from the groupconsisting of an elastic band, an elastic disk, a torsional energy storyelement, and a bellevile type spring.
 19. The assembly in claim 17,wherein the rotating member is a gear-shaped member.